Cleared Traditional

K931482 - STRYKER MPS ACUTE CARE BED

K931482 is the FDA 510(k) clearance for STRYKER MPS ACUTE CARE BED by Stryker Corp.. It is a Class 2 General Hospital device (product code FNL) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K931482 · Stryker Corp. · General Hospital
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Sep 1993
Decision
169d
Days
Class 2
Risk

K931482 is an FDA 510(k) clearance for the STRYKER MPS ACUTE CARE BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Stryker Corp. (Portage, US). The FDA issued a Cleared decision on September 9, 1993 after a review of 169 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5100 - 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 Corp. devices

Submission Details

510(k) Number K931482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1993
Decision Date September 09, 1993
Days to Decision 169 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 129d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FNL Bed, Ac-powered Adjustable Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5100
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 - FNL Bed, Ac-powered Adjustable Hospital

All 15
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K931482.
BARIKARE PLUS
K945664 · Kinetic Concepts, Inc. · Feb 1995
MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES
K932663 · Medline Industries, Inc. · Nov 1993
GLENN BED
K931581 · Kinetic Concepts, Inc. · Oct 1993
THE ADVANCE SERIES FROM HILL-ROM
K922352 · Hill-Rom, Inc. · Oct 1992
CRITICAL CARE HOSPITAL BED (ICU/CCU)
K915437 · Hill-Rom, Inc. · Jun 1992
INVACARE EXTENDED CARE NURSING HOME BED
K900151 · Invacare Corp. · Jun 1990