Cleared Traditional

K210288 - Disposable Manual Resuscitator

K210288 is an FDA 510(k) clearance for Disposable Manual Resuscitator, manufactured by Xiamen Compower Medical Tech. Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K210288 · Xiamen Compower Medical Tech. Co., Ltd. · Anesthesiology device
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Aug 2021
Decision
205d
Days
Class 2
Risk

K210288 is an FDA 510(k) clearance for the Disposable Manual Resuscitator. 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 August 26, 2021 after a review of 205 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Xiamen Compower Medical Tech. Co., Ltd. devices

FDA 510(k) Submission Details - K210288

510(k) Number K210288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2021
Decision Date August 26, 2021
Days to Decision 205 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 140d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Zi-medical, Inc.
Mingzi Hussey

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 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K210288.
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Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
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