Cleared Traditional

K924005 - SANKEN MAT

K924005 is an FDA 510(k) clearance for SANKEN MAT, manufactured by Shima American Corp.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K924005 · Shima American Corp. · General Hospital
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Jun 1993
Decision
311d
Days
Class 2
Risk

K924005 is an FDA 510(k) clearance for the SANKEN MAT. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Shima American Corp. (Washington, US). The FDA issued a Cleared decision on June 17, 1993 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shima American Corp. devices

FDA 510(k) Submission Details - K924005

510(k) Number K924005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1992
Decision Date June 17, 1993
Days to Decision 311 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 129d · This submission: 311d
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 K924005.
PRESSUREGUARD IV
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HUNTLEIGH DYNAMIC FLOTATION SYSTEM
K890012 · Huntleigh Technology, Inc. · Mar 1989