Cleared Traditional

K915750 - DISPOSABLE BACTERIAL BREATHNG FILTER (FDA 510(k) Clearance)

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

K915750 · Hospitak, Inc. · General Hospital
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Nov 1994
Decision
1077d
Days
Class 2
Risk

K915750 is an FDA 510(k) clearance for the DISPOSABLE BACTERIAL BREATHNG FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Hospitak, Inc. (Lindenhurst, US). The FDA issued a Cleared decision on November 30, 1994 after a review of 1077 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 Hospitak, Inc. devices

Submission Details

510(k) Number K915750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1991
Decision Date November 30, 1994
Days to Decision 1077 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
949d slower than avg
Panel avg: 128d · This submission: 1077d
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 200
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K915750.
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