Cleared Traditional

K770392 - MUFFLER

K770392 is an FDA 510(k) clearance for MUFFLER, manufactured by Cutter Laboratories, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770392 · Cutter Laboratories, Inc. · General Hospital
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Mar 1977
Decision
7d
Days
Class 2
Risk

K770392 is an FDA 510(k) clearance for the MUFFLER, AIR PUMP. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Cutter Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1977 after a review of 7 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 Cutter Laboratories, Inc. devices

FDA 510(k) Submission Details - K770392

510(k) Number K770392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1977
Decision Date March 07, 1977
Days to Decision 7 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
122d faster than avg
Panel avg: 129d · This submission: 7d
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 74
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K770392.
COPPER-TRAP
K781696 · Olympic Medical Corp. · Nov 1978
HUMIDIFIER FILTER
K780535 · Hudson Oxygen Therapy Sales Co. · Apr 1978
RESPIRATORY KIT
K772047 · American Hospital Supply Corp. · Nov 1977
FILTER, AIR, CUTTER MAINLINE
K770375 · Cutter Laboratories, Inc. · Mar 1977
FILTER, NEBULIZER, CUTTER
K770376 · Cutter Laboratories, Inc. · Mar 1977
3M BRAND ANESTHESIA FILTER,#3110
K760611 · 3M Company · Sep 1976