Cleared Traditional

K852422 - MODEL 500 PEDIATRIC STRETCHER/CRIB

K852422 is an FDA 510(k) clearance for MODEL 500 PEDIATRIC STRETCHER/CRIB, manufactured by Midmark Corp.. The device is a Class 2 General Hospital device with product code FMS cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K852422 · Midmark Corp. · General Hospital
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Jul 1985
Decision
28d
Days
Class 2
Risk

K852422 is an FDA 510(k) clearance for the MODEL 500 PEDIATRIC STRETCHER/CRIB. Classified as Bed, Pediatric Open Hospital (product code FMS), Class II - Special Controls.

Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5140 - 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 - K852422

510(k) Number K852422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1985
Decision Date July 05, 1985
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMS Device Classification - Class 2, Special Controls

Product Code FMS Bed, Pediatric Open Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5140
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 - FMS Bed, Pediatric Open Hospital

All 26
Devices cleared under the same product code (FMS) and FDA review panel - the closest regulatory comparables to K852422.
SWEET DREEMS SIMULATOR
K860596 · Sweet Dreams, Inc. · Mar 1986
NURSERY AMBIENT LIGHT METER
K860120 · Rocky Mountain Medical Corp. · Feb 1986
N.K. PEDIATRIC CRIBS
K853355 · N.K. Medical Products, Inc. · Sep 1985
MERIVAARA CRIB TROLLEY-MODEL 381
K852173 · Daun International, Inc. · Jun 1985
PEDICRAFT BED, MODEL B2944
K821773 · Pedicraft, Inc. · Jun 1982
TAB PEDIATRIC CRIB
K810728 · Cambridge Scientific · Apr 1981
K852422 · MODEL 500 PEDIATRIC STRETCHER/CRIB
Download PDF Midmark Corp.