Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd.
Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd.: 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd. Its amount of 29 is below the median of 138 (7th percentile). Dated 20 days ago, it is in the active follow-up window. Score 41/100. As of 2026-11-04, 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: 29 · 7th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263254 |
| Device | Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) |
| Applicant | Xiamen Compower Medical Tech. Co., Ltd. |
| Specialty / panel | Anesthesiology |
| Product code | BTM |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-17 |
| Decision date | 2026-10-16 |
| Review time (days) | 29 |
| Third-party review | No |
| Applicant location | Xiamen, CN |
| amount percentile | 7th of 414 (median 138, 0.2x median) |
| Peer records CSV (76 CN 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: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · BreathCare PAP III (YH-390N) (K260251) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd.'s amount: 7th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 29-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 20 days ago.
What is the FDAPulse record for Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd.?
Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254) by Xiamen Compower Medical Tech. Co., Ltd. was cleared on 2026-10-16 after 29 days of review.
How does Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd. compare to other FDAPulse records?
Its amount of 29 is below the median (7th percentile); smaller records often move faster and face less competition. It is 20 days old, still within a typical 45-day follow-up window.
Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254) | CN | 2026-10-16 |
| BreathCare PAP III (YH-390N) (K260251) | CN | 2026-10-23 |
| Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289) | CN | 2026-09-23 |
| Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171) | CN | 2026-09-18 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Anesthesiology devices
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