FDAPulse / report
Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc.
Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc. (California): 510(k) cleared for Route 92 Medical, Inc. Its amount of 28 is below the median of 138 (6th percentile). Dated 19 days ago, it is in the active follow-up window. Score 41/100. 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: 28 · 6th percentile of 414 FDAPulse records · 0.2x 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 | K263266 |
| Device | Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set |
| Applicant | Route 92 Medical, Inc. |
| Specialty / panel | Cardiovascular |
| Product code | NRY |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-18 |
| Decision date | 2026-10-16 |
| Review time (days) | 28 |
| Third-party review | No |
| Applicant location | San Mateo, CA, US |
| amount percentile | 6th of 414 (median 138, 0.2x median) |
| Peer records CSV (76 CA 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: 2026-10-16
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc.'s amount: 6th 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)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 28-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 19 days ago.
What is the FDAPulse record for Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc. in California?
Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266) by Route 92 Medical, Inc. was cleared on 2026-10-16 after 28 days of review.
How does Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc. compare to other California FDAPulse records?
Its amount of 28 is below the median (6th percentile); smaller records often move faster and face less competition. It is 19 days old, still within a typical 45-day follow-up window.
Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266) | CA | 2026-10-16 |
| QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (K260250) | CA | 2026-09-29 |
| DistaSense(TM) (v1) (K254058) | CA | 2026-09-25 |
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