Cleared Traditional

K811684 - AMERICAN AIRCARE SYSTEM

K811684 is an FDA 510(k) clearance for AMERICAN AIRCARE SYSTEM, manufactured by American Hamilton. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K811684 · American Hamilton · General Hospital
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Jul 1981
Decision
17d
Days
Class 2
Risk

K811684 is an FDA 510(k) clearance for the AMERICAN AIRCARE SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by American Hamilton (Mchenry, US). The FDA issued a Cleared decision on July 2, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5550 - 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 American Hamilton devices

FDA 510(k) Submission Details - K811684

510(k) Number K811684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1981
Decision Date July 02, 1981
Days to Decision 17 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
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNM Device Classification - Class 2, Special Controls

Product Code FNM Mattress, Air Flotation, Alternating Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5550
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 - FNM Mattress, Air Flotation, Alternating Pressure

All 52
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K811684.
HUNTLEIGH BETA II HM85
K870681 · Huntleigh Technology, Inc. · Mar 1987
HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP
K844879 · Huntleigh Technology, Inc. · Jan 1985
HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES
K844880 · Huntleigh Technology, Inc. · Jan 1985
ABCO/GRANT ALTERNATING PRESSURE PAD & UT
K800231 · Abco Dealers, Inc. · Feb 1980
AIR-FLO ALTERNATING PRESSURE PAD SYSTEM
K780906 · Gaymar Industries, Inc. · Aug 1978
AERO PULSE ALTERNATING PRES. PUMP
K771463 · Medline Industries, Inc. · Aug 1977