Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices
Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices (Massachusetts): 510(k) cleared for Analog Devices. Its amount of 219 is above the median of 138 (71st percentile). Dated 19 days ago, it is in the active follow-up window. Score 48/100. As of 2026-11-03, 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: 219 · 71th percentile of 414 FDAPulse records · 1.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260801 |
| Device | Sensinel Cardiopulmonary Management (CPM) System |
| Applicant | Analog Devices |
| Specialty / panel | Cardiovascular |
| Product code | MWI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-11 |
| Decision date | 2026-10-16 |
| Review time (days) | 219 |
| Third-party review | No |
| Applicant location | Wilmington, MA, US |
| amount percentile | 71th of 414 (median 138, 1.6x median) |
| Peer records CSV (41 MA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices
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 MA records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices + all 41 MA 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: 2026-10-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (MA first): GSPE Spacer (K260063) · multiFiltratePRO System (K261203) · a2z-Abdo-Triage (K260906) · BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125) · Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 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: Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices's amount: 71st percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 219-day review, longer than typical.
- Posted 19 days ago.
What is the FDAPulse record for Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices in Massachusetts?
Sensinel Cardiopulmonary Management (CPM) System (K260801) by Analog Devices was cleared on 2026-10-16 after 219 days of review.
How does Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices compare to other Massachusetts FDAPulse records?
Its amount of 219 sits in the upper half (71th percentile) of 414 records; the median is 138. It is 19 days old, still within a typical 45-day follow-up window.
Sensinel Cardiopulmonary Management (CPM) System (K260801) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Sensinel Cardiopulmonary Management (CPM) System (K260801) | MA | 2026-10-16 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
Related records
- Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC
- TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences
- Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation
- eClinics (K260075): 510(k) cleared for Ceiba Healthcare US, Inc.
- MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.
- OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp.
- ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.
- QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (K260250): 510(k) cleared for QT Medical, Inc.
- DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies
- S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.
- Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.
- Echo-2 (K254240): 510(k) cleared for Neko Health AB
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
More Massachusetts public-record feeds
FEMA Hazard Mitigation Project Tracker in Massachusetts Nursing Home Inspection Deficiencies by State & Severity in Massachusetts Federal Alcohol Permit Holder Directory in Massachusetts New NIH Research Awards by Organization in Massachusetts New FDA Medical Device Listings by Manufacturer, CMO & Sterilizer in Massachusetts School & Library E-Rate Contracts Up for Rebid in Massachusetts New & Re-Approved E-Rate Service Providers (FCC Form 498 / SPIN) in Massachusetts New FDA PMA Device, NDA, Generic (ANDA), BLA & Drug Supplement Approvals by Sponsor in Massachusetts
How to monitor Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices and peer cardiovascular records
Get new FDAPulse records like Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices 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.