OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp.
OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp. (Georgia): 510(k) cleared for Cognition Medical Corp. Its amount of 366 is top-decile (98th percentile of 414 records). Dated 33 days ago, it serves as a historical benchmark. Score 61/100. 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: 366 · 98th percentile of 414 FDAPulse records · 2.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 68 related GA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K253422 |
| Device | OAB Delivery Catheter |
| Applicant | Cognition Medical Corp. |
| Specialty / panel | Cardiovascular |
| Product code | QJP |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-10-01 |
| Decision date | 2026-10-02 |
| Review time (days) | 366 |
| Third-party review | No |
| Applicant location | Atlanta, GA, US |
| amount percentile | 98th of 414 (median 138, 2.7x median) |
| Peer records CSV (69 GA 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: 2026-10-02
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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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: OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp. and 69 Georgia peers
- Georgia FDAPulse records like this one: 69
- OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp.'s amount: 98th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Georgia peer: $13,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 366-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 33 days ago.
What is the FDAPulse record for OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp. in Georgia?
OAB Delivery Catheter (K253422) by Cognition Medical Corp. was cleared on 2026-10-02 after 366 days of review.
How does OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp. compare to other Georgia FDAPulse records?
This is a top-decile record: its amount of 366 is 2.7x the median of 138 across 414 records. It is 33 days old, still within a typical 45-day follow-up window.
OAB Delivery Catheter (K253422) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| OAB Delivery Catheter (K253422) | GA | 2026-10-02 |
| 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 |
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