Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.
Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.: 510(k) cleared for Aevice Health Pte. , Ltd. Its amount of 248 is above the median of 138 (79th percentile). Dated 40 days ago, it serves as a historical benchmark. 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: 248 · 79th percentile of 414 FDAPulse records · 1.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related SG FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260140 |
| Device | Aevice Wheeze Detection Module |
| Applicant | Aevice Health Pte. , Ltd. |
| Specialty / panel | Anesthesiology |
| Product code | PHZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-20 |
| Decision date | 2026-09-25 |
| Review time (days) | 248 |
| Third-party review | No |
| Applicant location | Singapore, SG |
| amount percentile | 79th of 414 (median 138, 1.8x median) |
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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: 2026-09-25
- 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: Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd. and 4 SG peers
- SG FDAPulse records like this one: 4
- Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.'s amount: 79th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every SG peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 248-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 40 days ago.
What is the FDAPulse record for Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.?
Aevice Wheeze Detection Module (K260140) by Aevice Health Pte. , Ltd. was cleared on 2026-09-25 after 248 days of review.
How does Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd. compare to other FDAPulse records?
Its amount of 248 sits in the upper half (79th percentile) of 414 records; the median is 138. It is 40 days old, still within a typical 45-day follow-up window.
Aevice Wheeze Detection Module (K260140) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Aevice Wheeze Detection Module (K260140) | SG | 2026-09-25 |
| BreathCare PAP III (YH-390N) (K260251) | CN | 2026-10-23 |
| Helo Return (K253717) | CA | 2026-10-11 |
| Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289) | CN | 2026-09-23 |
Compare Aevice Wheeze Detection Module (K260140) vs Profoject LOR Syringe (K261372) →
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Anesthesiology devices
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