Cleared Traditional

K935949 - STRYKER 5000

K935949 is an FDA 510(k) clearance for STRYKER 5000, manufactured by Stryker Medical. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K935949 · Stryker Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
186d
Days
Class 2
Risk

K935949 is an FDA 510(k) clearance for the STRYKER 5000. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on June 17, 1994 after a review of 186 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Stryker Medical devices

FDA 510(k) Submission Details - K935949

510(k) Number K935949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1993
Decision Date June 17, 1994
Days to Decision 186 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
57d slower than avg
Panel avg: 129d · This submission: 186d
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 15
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K935949.
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
K961854 · Gaymar Industries, Inc. · Aug 1996
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
K960411 · Invacare Corp. · Mar 1996
TRIADYNE
K944094 · Kinetic Concepts, Inc. · May 1995
TURBO II
K933402 · Kinetic Concepts, Inc. · Mar 1994
PREMIUM
K930673 · Kinetic Concepts, Inc. · Aug 1993
PROFILE, A CRITICAL CARE LOW AIR LOSS BED
K901901 · Kinetic Concepts, Inc. · Oct 1990