Cleared Traditional

K961838 - RESPIRGARD II, SPIROGARD

K961838 is an FDA 510(k) clearance for RESPIRGARD II, 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 158-day FDA review.

K961838 · Marquest Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K961838

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.

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 145
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K961838.
9000 SERIES FILTER & FILTER/HME
K963053 · Enternet Medical, Inc. · Feb 1997
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · Mallinckrodt Medical · Nov 1996
ENGSTROM HMEF 1000
K964204 · Datex Engstrom AB · Nov 1996
MERCURY MEDICAL CPR BAG EXHALATION FILTER
K954490 · Mercury Medical · Oct 1996
BACTERIA/VIRAL FILTER
K961914 · Hudson Respiratory Care, Inc. · Aug 1996
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
K954828 · Gibeck, Inc. · May 1996