Cleared Traditional

K842580 - ACCESSORY FOR ADULT VOL. VENTILATOR

K842580 is an FDA 510(k) clearance for ACCESSORY FOR ADULT VOL. VENTILATOR, manufactured by Infrasonics Corp.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K842580

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
Combination Product No
PCCP Authorized No
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.

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 108
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K842580.
PALL GAS LINE GUARDIAN FILTER
K850327 · Pall Biomedical Products Co. · Feb 1985
MEDIPART FILTER & TUBING MP-02X
K844491 · Medipart Jerry Alexander · Dec 1984
MEDIPART BACTERIA FILTER MP-30X
K844492 · Medipart Jerry Alexander · Dec 1984
FILTER-FLEX
K841236 · Life Design Systems, Inc. · Apr 1984
PALL COALESCER
K840960 · Pall Biomedical Products Co. · Mar 1984
DRYDEN MINI BACTERIA FILTER
K840205 · Dryden Corp. · Feb 1984