BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc.
BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc. (California): 510(k) cleared for Deep Breathe, Inc. Its amount of 155 is above the median of 138 (58th percentile). Dated 13 days ago, it is in the active follow-up window. Score 54/100. 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: 155 · 58th percentile of 414 FDAPulse records · 1.1x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261679 |
| Device | BlineSlide |
| Applicant | Deep Breathe, Inc. |
| Specialty / panel | Radiology |
| Product code | POK |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-21 |
| Decision date | 2026-10-23 |
| Review time (days) | 155 |
| Third-party review | No |
| Applicant location | London, CA |
| amount percentile | 58th of 414 (median 138, 1.1x median) |
| Peer records CSV (76 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc.
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 CA records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock BlineSlide (K261679): 510(k) cleared for Deep Breathe + all 76 CA 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: 2026-10-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CA first): Triever Duo Catheter (K253419) · Helo Return (K253717) · DistaSense(TM) (v1) (K254058) · BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cyto · CapsoView (CVV); CapsoCloud (CLD) (K254230) · 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: BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc.'s amount: 58th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
54 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 155-day review, longer than typical.
- Posted 13 days ago.
What is the FDAPulse record for BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc. in California?
BlineSlide (K261679) by Deep Breathe, Inc. was cleared on 2026-10-23 after 155 days of review.
How does BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc. compare to other California FDAPulse records?
Its amount of 155 sits in the upper half (58th percentile) of 414 records; the median is 138. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
BlineSlide (K261679) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| BlineSlide (K261679) | CA | 2026-10-23 |
| VenusCT (K260510) | CA | 2026-10-19 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
Related records
- VenusCT (K260510): 510(k) cleared for Linatech, LLC
- AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.
- Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc.
- syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc.
- Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.
- OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd.
- BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC
- Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd.
- PV-iCurve Pro (K261531): 510(k) cleared for Perception Vision Medical Technology Co., Ltd.
- Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa
- Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd.
- QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Radiology devices
More California public-record feeds
New Trucking Company Registrations in California FMCSA Trucking Insurance Cancellations by Carrier, Insurer & Fleet Size in California New Executive & Auditor Changes (SEC 8-K) in California Carrier Out-of-Service Alerts in California Newly CLIA-Certified Laboratories by State & Certificate in California New WARN Act Layoff & Closure Notices with Headcount and Site Address in California New MSHA Citations at Mines & Quarries by State in California DOE grid resilience Award Tracker in California
How to monitor BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc. and peer radiology records
Get new FDAPulse records like BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc. 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.