Cleared Traditional

CPR Face Shield (K192285) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192285 · Firstar Healthcare Company Limited (Guangzhou) · Anesthesiology device
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Nov 2020
Decision
461d
Days
Class 2
Risk

K192285 is an FDA 510(k) clearance for the CPR Face Shield. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Firstar Healthcare Company Limited (Guangzhou) (Guangzhou, CN). The FDA issued a Cleared decision on November 25, 2020 after a review of 461 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Firstar Healthcare Company Limited (Guangzhou) devices

Submission Details

510(k) Number K192285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2019
Decision Date November 25, 2020
Days to Decision 461 days
Submission Type Traditional
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
322d slower than avg
Panel avg: 139d · This submission: 461d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 Truthful Information Technology Co., Ltd.
Boyle Wang

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.

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