Cleared Traditional

K802763 - RESPIRGARD

K802763 is an FDA 510(k) clearance for RESPIRGARD, manufactured by Marquest Medical Products, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K802763 · Marquest Medical Products, Inc. · General Hospital
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Nov 1980
Decision
22d
Days
Class 2
Risk

K802763 is an FDA 510(k) clearance for the RESPIRGARD. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Marquest Medical Products, Inc. (Englewood, US). The FDA issued a Cleared decision on November 26, 1980 after a review of 22 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.

View all Marquest Medical Products, Inc. devices

FDA 510(k) Submission Details - K802763

510(k) Number K802763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1980
Decision Date November 26, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - CAH Filter, Bacterial, Breathing-circuit

All 147
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K802763.
BREATHING FILTER
K830618 · Ohio Medical Products · Apr 1983
NON-REUSABLE UNIVERSAL NEBULIZER FILTE
K823257 · Ohio Medical Products · Dec 1982
6-435 FILTER PAD, 5/PKG.
K802914 · Lifecare Services, Inc. · Dec 1980
DRYDEN BACTERIA FILTER
K792097 · Dryden Corp. · Nov 1979
VENTILATOR TUBE WITH FILTER
K791773 · Pharmaseal Div., Baxter Healthcare Corp. · Oct 1979
UNIPOR BREATHING CIRCUIT FILTER
K791307 · Pall Biomedical Products Co. · Aug 1979