Cleared Traditional

GGM Breathing Circuit Bacterial Filter (K210352) - FDA 510(k) Clearance

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

K210352 · Great Group Medical Co, Ltd. · General Hospital
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Mar 2022
Decision
412d
Days
Class 2
Risk

K210352 is an FDA 510(k) clearance for the GGM Breathing Circuit Bacterial Filter. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Great Group Medical Co, Ltd. (Chaughua County, TW). The FDA issued a Cleared decision on March 27, 2022 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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 General Hospital submissions.

View all Great Group Medical Co, Ltd. devices

Submission Details

510(k) Number K210352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2021
Decision Date March 27, 2022
Days to Decision 412 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
283d slower than avg
Panel avg: 129d · This submission: 412d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 19
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K210352.
Filter and HME/Filter
K221472 · Ningbo Huakun Medical Equipment Co., Ltd. · Feb 2023
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
K221836 · Dr?gerwerk AG & Co KGaA · Dec 2022
EasyOne Filter
K221250 · Ndd Medizintechnik AG · Nov 2022
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
K211286 · Pall Corporation · Nov 2021
Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
K202459 · Pharma System AB · Sep 2021
HepaShield Bacterial Viral Breathing System Filter
K191909 · Flexicare Medical Limited. · Mar 2020