Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc.
Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc. (California): 510(k) cleared for Inari Medical, Inc. Its amount of 352 is top-decile (97th percentile of 414 records). Dated 47 days ago, it serves as a historical benchmark. Score 55/100. 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: 352 · 97th percentile of 414 FDAPulse records · 2.6x 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 | K253419 |
| Device | Triever Duo Catheter |
| Applicant | Inari Medical, Inc. |
| Specialty / panel | Cardiovascular |
| Product code | QEW |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-10-01 |
| Decision date | 2026-09-18 |
| Review time (days) | 352 |
| Third-party review | No |
| Applicant location | Irvine, CA, US |
| amount percentile | 97th of 414 (median 138, 2.6x median) |
| Peer records CSV (76 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-09-18
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (CA first): Helo Return (K253717) · DistaSense(TM) (v1) (K254058) · BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cyto · CapsoView (CVV); CapsoCloud (CLD) (K254230) · Carecube Negative Pressure Isolation Chamber (1BY) (K260180) · 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
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Peer benchmark and outreach value: Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc.'s amount: 97th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 352-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc. in California?
Triever Duo Catheter (K253419) by Inari Medical, Inc. was cleared on 2026-09-18 after 352 days of review.
How does Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc. compare to other California FDAPulse records?
This is a top-decile record: its amount of 352 is 2.6x the median of 138 across 414 records. It is 47 days old; check the official source for later updates before acting.
Triever Duo Catheter (K253419) vs. top 2 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| Triever Duo Catheter (K253419) | CA | 2026-09-18 | This record |
| QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (K260250) | CA | 2026-09-29 | View record → |
| DistaSense(TM) (v1) (K254058) | CA | 2026-09-25 | Compare Triever Duo Catheter (K253419) vs DistaSense(TM) (v1) (K254058) → |
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