SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation
SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation (Texas): 510(k) cleared for BridgeSource Medical Corporation. Its amount of 189 is above the median of 138 (67th percentile). Dated 37 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: 189 · 67th percentile of 414 FDAPulse records · 1.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related TX FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | DEN260007 |
| Device | SmartRead(TM) Medical Device Identifier (4100) |
| Applicant | BridgeSource Medical Corporation |
| Specialty / panel | Cardiovascular |
| Product code | SJJ |
| Device class | 2 |
| Clearance type | Direct |
| Decision | Unknown |
| Received | 2026-03-24 |
| Decision date | 2026-09-29 |
| Review time (days) | 189 |
| Third-party review | No |
| Applicant location | Austin, TX, US |
| amount percentile | 67th of 414 (median 138, 1.4x median) |
| Peer records CSV (12 TX records) | 🔒 Click to unlock → |
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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: 2026-09-29
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (TX first): MyoVista wavECG (DG-200-B15-003) (K260005) · Small Diameter Core Wire (CMAN-000-00); Small Diameter Core · Kinetic Software Library (K260640) · DASH Flu A/B Test (K261347) · Ntegrate Threaded Nail System (K261961) · 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
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Peer benchmark and outreach value: SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation and 12 Texas peers
- Texas FDAPulse records like this one: 12
- SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation's amount: 67th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Texas peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 189-day review, longer than typical.
- Posted 37 days ago.
What is the FDAPulse record for SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation in Texas?
SmartRead(TM) Medical Device Identifier (4100) (DEN260007) by BridgeSource Medical Corporation was cleared on 2026-09-29 after 189 days of review.
How does SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation compare to other Texas FDAPulse records?
Its amount of 189 sits in the upper half (67th percentile) of 414 records; the median is 138. It is 37 days old, still within a typical 45-day follow-up window.
SmartRead(TM) Medical Device Identifier (4100) (DEN260007) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| SmartRead(TM) Medical Device Identifier (4100) (DEN260007) | TX | 2026-09-29 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
| MyoVista wavECG (DG-200-B15-003) (K260005) | TX | 2026-10-05 |
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