Cleared Special

K263254 - Disposable Manual Resuscitator (NPVC-001/RTMA

Also marketed or referenced as:
NPVC-002/RTMA NPVC-003/RTMA1)

K263254 is an FDA 510(k) clearance for Disposable Manual Resuscitator (NPVC-00..., manufactured by Xiamen Compower Medical Tech. Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Special 510(k) pathway after a 29-day FDA review.

K263254 · Xiamen Compower Medical Tech. Co., Ltd. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Oct 2026
Decision
29d
Days
Class 2
Risk

K263254 is an FDA 510(k) clearance for the Disposable Manual Resuscitator (NPVC-001/RTMA. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Xiamen Compower Medical Tech. Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on October 16, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K263254

510(k) Number K263254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2026
Decision Date October 16, 2026
Days to Decision 29 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 140d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Shanghai Sungo Management Consulting Co., Ltd.
Eva Li

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTM Ventilator, Emergency, Manual (resuscitator)

All 209
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K181583 · Flexicare Medical Limited. · Dec 2018
K263254 · Disposable Manual Resuscitator (NPVC-001/RTMA
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