Cleared Traditional

K803307 - MATTRESS

K803307 is the FDA 510(k) clearance for MATTRESS by Intl. Medical Equipment Corp.. It is a Class 2 General Hospital device (product code FNM) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K803307 · Intl. Medical Equipment Corp. · General Hospital
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Jan 1981
Decision
14d
Days
Class 2
Risk

K803307 is an FDA 510(k) clearance for the MATTRESS, AIR FLOATATION, ALTERN. PRESS.. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Intl. Medical Equipment Corp. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1981 after a review of 14 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 Intl. Medical Equipment Corp. devices

Submission Details

510(k) Number K803307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1980
Decision Date January 13, 1981
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K803307.
PREMIUM
K930673 · Kinetic Concepts, Inc. · Aug 1993
PROFILE, A CRITICAL CARE LOW AIR LOSS BED
K901901 · Kinetic Concepts, Inc. · Oct 1990
PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
K872228 · American Pharmaseal Div. Ahsc · Sep 1987
ABCO/GRANT ALTERNATING PRESSURE PAD & UT
K800231 · Abco Dealers, Inc. · Feb 1980
AERO PULSE ALTERNATING PRES. PUMP
K771463 · Medline Industries, Inc. · Aug 1977