Helo Return (K253717): 510(k) cleared for Endovascular Engineering, Inc.
Helo Return (K253717): 510(k) cleared for Endovascular Engineering, Inc. (California): 510(k) cleared for Endovascular Engineering, Inc. Its amount of 321 is top-decile (97th percentile of 414 records). Dated 24 days ago, it is in the active follow-up window. Score 61/100. 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: 321 · 97th percentile of 414 FDAPulse records · 2.3x 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 | K253717 |
| Device | Helo Return |
| Applicant | Endovascular Engineering, Inc. |
| Specialty / panel | Anesthesiology |
| Product code | SHJ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-11-24 |
| Decision date | 2026-10-11 |
| Review time (days) | 321 |
| Third-party review | No |
| Applicant location | Menlo Park, CA, US |
| amount percentile | 97th of 414 (median 138, 2.3x 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: 2026-10-11
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Helo Return (K253717): 510(k) cleared for Endovascular Engineering, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- Helo Return (K253717): 510(k) cleared for Endovascular Engineering, Inc.'s amount: 97th 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)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 321-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 24 days ago.
What is the FDAPulse record for Helo Return (K253717): 510(k) cleared for Endovascular Engineering, Inc. in California?
Helo Return (K253717) by Endovascular Engineering, Inc. was cleared on 2026-10-11 after 321 days of review.
How does Helo Return (K253717): 510(k) cleared for Endovascular Engineering, Inc. compare to other California FDAPulse records?
This is a top-decile record: its amount of 321 is 2.3x the median of 138 across 414 records. It is 24 days old, still within a typical 45-day follow-up window.
Helo Return (K253717) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Helo Return (K253717) | CA | 2026-10-11 |
| BreathCare PAP III (YH-390N) (K260251) | CN | 2026-10-23 |
| Aevice Wheeze Detection Module (K260140) | SG | 2026-09-25 |
| Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289) | CN | 2026-09-23 |
Related records
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- Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd.
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