Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH
Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH (Delaware): 510(k) cleared for CNSAC Medshop GmbH. Its amount of 185 is above the median of 138 (65th percentile). Dated 42 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 185 · 65th percentile of 414 FDAPulse records · 1.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260949 |
| Device | Disposable Belts for Polysomnography (CNSAC) |
| Applicant | CNSAC Medshop GmbH |
| Specialty / panel | Anesthesiology |
| Product code | MNR |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-23 |
| Decision date | 2026-09-24 |
| Review time (days) | 185 |
| Third-party review | No |
| Applicant location | Theilheim, DE |
| amount percentile | 65th of 414 (median 138, 1.3x median) |
| Peer records CSV (25 DE records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of DE records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH + all 25 DE records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-24
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (DE first): colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gas · Endox High Level Disinfectant (K254094) · Actolind® (06.3637. Actolind® Gel Plus) (K254168) · UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operat · KARL STORZ SUPRALOOP (K254303) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH's amount: 65th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 185-day review, longer than typical.
- Posted 42 days ago.
What is the FDAPulse record for Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH in Delaware?
Disposable Belts for Polysomnography (CNSAC) (K260949) by CNSAC Medshop GmbH was cleared on 2026-09-24 after 185 days of review.
How does Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH compare to other Delaware FDAPulse records?
Its amount of 185 sits in the upper half (65th percentile) of 414 records; the median is 138. It is 42 days old, still within a typical 45-day follow-up window.
Disposable Belts for Polysomnography (CNSAC) (K260949) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Disposable Belts for Polysomnography (CNSAC) (K260949) | DE | 2026-09-24 |
| BreathCare PAP III (YH-390N) (K260251) | CN | 2026-10-23 |
| Helo Return (K253717) | CA | 2026-10-11 |
| Aevice Wheeze Detection Module (K260140) | SG | 2026-09-25 |
Related records
- BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.
- Helo Return (K253717): 510(k) cleared for Endovascular Engineering, Inc.
- Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.
- Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd.
- Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation
- Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd.
- Profoject LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd.
- Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc.
- ElintMAX Respiratory Monitor (ElintMAX Monitor A1) (K260226): 510(k) cleared for Amptron Medical, Inc.
- Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd.
- Glucommander (K261939): 510(k) cleared for Glytec, LLC
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Anesthesiology devices
More Delaware public-record feeds
Delaware Public Education Organization Directory Pulse in Delaware Largest U.S. Greenhouse Gas Emitters by Company, Sector & State (EPA GHGRP) in Delaware FEMA Hazard Mitigation Project Tracker in Delaware Federal Alcohol Permit Holder Directory in Delaware New NSF Research Awards by Institution in Delaware School & Library E-Rate Contracts Up for Rebid in Delaware New Grants by Vendor Procurement Need in Delaware Carrier Out-of-Service Alerts in Delaware
How to monitor Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH and peer anesthesiology records
Get new FDAPulse records like Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.