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Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd. vs Profoject LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd.: FDAPulse comparison
Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.'s review days of 248 is 1.6x Profoject LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd.'s 151 (79th percentile). Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd. is dated 2026-09-25; Profoject LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd. 2026-09-25.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd. compare to Profoject LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd.?
| Field | Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd. | Profoject LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K260140 | K261372 |
| Device | Aevice Wheeze Detection Module | Profoject LOR Syringe |
| Applicant | Aevice Health Pte. , Ltd. | CMT Health PTE., Ltd. |
| Specialty / panel | Anesthesiology | Anesthesiology |
| Product code | PHZ | CAZ |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-01-20 | 2026-04-27 |
| Decision date | 2026-09-25 | 2026-09-25 |
| Review time (days) | 248 | 151 |
| Third-party review | No | No |
| Applicant location | Singapore, SG | Singapore, SG |
| amount percentile | 79th | 56th |
| Predicate Speed & CAPA Advisory Opportunity Score | 61/100 | 48/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd. · Profoject LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd.
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