Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd.
Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. (Illinois): 510(k) cleared for Rapid-Medical , Ltd. Its amount of 358 is top-decile (98th percentile of 414 records). Dated 47 days ago, it serves as a historical benchmark. Score 60/100. 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: 358 · 98th percentile of 414 FDAPulse records · 2.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K253146 |
| Device | Hyperdrive 35 Guidewire |
| Applicant | Rapid-Medical , Ltd. |
| Specialty / panel | Cardiovascular |
| Product code | DQX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-09-25 |
| Decision date | 2026-09-18 |
| Review time (days) | 358 |
| Third-party review | Yes |
| Applicant location | Yokneam, IL |
| amount percentile | 98th of 414 (median 138, 2.6x median) |
| Peer records CSV (57 IL 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 (IL first): SmartIPL_NI System (K241973) · Tempus ECG-MR (K254297) · Ecomed Disposable Administration Sets (K254123) · TumorSight Risk (K260023) · LuxDesign (K260421) · 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: Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd.'s amount: 98th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 358-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Reviewed through the third-party program.
What is the FDAPulse record for Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. in Illinois?
Hyperdrive 35 Guidewire (K253146) by Rapid-Medical , Ltd. was cleared on 2026-09-18 after 358 days of review.
How does Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. compare to other Illinois FDAPulse records?
This is a top-decile record: its amount of 358 is 2.6x the median of 138 across 414 records. It is 47 days old; check the official source for later updates before acting.
Hyperdrive 35 Guidewire (K253146) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Hyperdrive 35 Guidewire (K253146) | IL | 2026-09-18 |
| 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 |
Compare Hyperdrive 35 Guidewire (K253146) vs Tempus ECG-MR (K254297) →
Related records
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