Cleared Traditional

K962045 - ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT

K962045 is an FDA 510(k) clearance for ANESTHESIA BREATHING CIRCUIT/ANESTHESIA..., manufactured by Mallinckrodt Medical. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K962045 · Mallinckrodt Medical · General Hospital
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Nov 1996
Decision
182d
Days
Class 2
Risk

K962045 is an FDA 510(k) clearance for the ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on November 26, 1996 after a review of 182 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 Mallinckrodt Medical devices

FDA 510(k) Submission Details - K962045

510(k) Number K962045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1996
Decision Date November 26, 1996
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
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 K962045.
POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
K965020 · Porous Media Corp. · Mar 1997
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
K964979 · Porous Media Corp. · Mar 1997
9000 SERIES FILTER & FILTER/HME
K963053 · Enternet Medical, Inc. · Feb 1997
ENGSTROM HMEF 1000
K964204 · Datex Engstrom AB · Nov 1996
RESPIRGARD II, SPIROGARD
K961838 · Marquest Medical Products, Inc. · Oct 1996
MERCURY MEDICAL CPR BAG EXHALATION FILTER
K954490 · Mercury Medical · Oct 1996