Cleared Traditional

K961838 - RESPIRGARD II

K961838 is the FDA 510(k) clearance for RESPIRGARD II by Marquest Medical Products, Inc.. It is a Class 2 General Hospital device (product code CAH) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K961838 · Marquest Medical Products, Inc. · General Hospital
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Oct 1996
Decision
158d
Days
Class 2
Risk

K961838 is an FDA 510(k) clearance for the RESPIRGARD II, SPIROGARD. 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 October 18, 1996 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Marquest Medical Products, Inc. devices

Submission Details

510(k) Number K961838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1996
Decision Date October 18, 1996
Days to Decision 158 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 129d · This submission: 158d
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 73
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K961838.
END EXPIRATORY FILTER, MODEL RT020
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AIRLIFE HEPA FILTER
K011132 · Allegiance Healthcare Corp. · Jun 2001
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · Mallinckrodt Medical · Nov 1996
PFT FILTER
K952062 · Intertech Resources, Inc. · Jun 1995
BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA
K951047 · Vital Signs, Inc. · Jun 1995
SPIROBAC ADAPTERS
K944124 · Mallinckrodt Medical · Sep 1994