Cleared Traditional

K875037 - STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED

K875037 is an FDA 510(k) clearance for STRYKER 1990 LIBERTY ELECTRIC CRITICAL ..., manufactured by Stryker Corp.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K875037 · Stryker Corp. · General Hospital
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Feb 1988
Decision
66d
Days
Class 2
Risk

K875037 is an FDA 510(k) clearance for the STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on February 11, 1988 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K875037

510(k) Number K875037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date February 11, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNL Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K875037.
MSI 3002 SERIES BED
K881963 · Med Service, Inc. · Jun 1988
MSI 5000 SERIES BED
K881965 · Med Service, Inc. · May 1988
MSI 2002 SERIES BED
K881027 · Med Service, Inc. · May 1988
MSI 9000 SERIES BED
K873291 · Med Service, Inc. · Dec 1987
PARAGON 9000 TILT AND TURN BED
K872923 · Surgi-Med, Inc. · Oct 1987
PARAGON 8500 CARDIO-PULMONARY BED
K872924 · Surgi-Med, Inc. · Oct 1987
K875037 · STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED
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