Cleared Traditional

K842580 - ACCESSORY FOR ADULT VOL. VENTILATOR

K842580 is the FDA 510(k) clearance for ACCESSORY FOR ADULT VOL. VENTILATOR by Infrasonics Corp.. It is a Class 2 General Hospital device (product code CAH) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K842580 · Infrasonics Corp. · General Hospital
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Aug 1984
Decision
52d
Days
Class 2
Risk

K842580 is an FDA 510(k) clearance for the ACCESSORY FOR ADULT VOL. VENTILATOR. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Infrasonics Corp. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1984 after a review of 52 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 Infrasonics Corp. devices

Submission Details

510(k) Number K842580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1984
Decision Date August 24, 1984
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 129d · This submission: 52d
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 29
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K842580.
BACTERIA FILTER
K912577 · Vital Signs, Inc. · Apr 1992
BACTERIA FILTER
K904830 · Vital Signs, Inc. · Apr 1991
OMNIFILTER MAIN FLOW BACTERIA FILTER
K890362 · Puritan Bennett Corp. · Mar 1989
GASLINE FILTER, #EC-GLF SERIES
K832935 · Gish Biomedical, Inc. · Nov 1983
BREATHING CIRCUIT BACTERIA FILTER
K831856 · Vital Signs, Inc. · Sep 1983
3M BRAND ANESTHESIA FILTER,#3110
K760611 · 3M Company · Sep 1976