Cleared Traditional

K101629 - FIL 1520

K101629 is an FDA 510(k) clearance for FIL 1520, manufactured by Glenn Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K101629 · Glenn Medical Systems, Inc. · General Hospital
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Jul 2010
Decision
29d
Days
Class 2
Risk

K101629 is an FDA 510(k) clearance for the FIL 1520. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Glenn Medical Systems, Inc. (Ne Canton, US). The FDA issued a Cleared decision on July 9, 2010 after a review of 29 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K101629

510(k) Number K101629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2010
Decision Date July 09, 2010
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

CAH Device Classification - Class 2, Special Controls

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

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 - CAH Filter, Bacterial, Breathing-circuit

All 196
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K101629.
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FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K101629 · FIL 1520
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