Cleared Traditional

K854304 - KEYMED OFFICE COUCH

K854304 is the FDA 510(k) clearance for KEYMED OFFICE COUCH by Keymed, Inc.. It is a Class 2 General Hospital device (product code FPO) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K854304 · Keymed, Inc. · General Hospital
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Nov 1985
Decision
18d
Days
Class 2
Risk

K854304 is an FDA 510(k) clearance for the KEYMED OFFICE COUCH. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Keymed, Inc. (Essex Ss2 5qh England, GB). The FDA issued a Cleared decision on November 12, 1985 after a review of 18 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6910 - 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.

View all Keymed, Inc. devices

Submission Details

510(k) Number K854304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1985
Decision Date November 12, 1985
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPO Stretcher, Wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6910
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 - FPO Stretcher, Wheeled

All 10
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K854304.
HILL-ROM VIA STRETCHER (P1300 - P1303)
K922808 · Hill-Rom, Inc. · Mar 1993
GENERAL PROCEDURAL STRETCHERS (P880- P886)
K922809 · Hill-Rom, Inc. · Mar 1993
MODEL #527 OPHTHALMIC STRETCHER
K904011 · Midmark Corp. · Oct 1990
THE KEYMED VARI-HEIGHT PATIENT COUCH
K853421 · Keymed, Inc. · Sep 1985
CENTURIAN HYDRAULIC STRETCHER
K843439 · American Sterilizer Co. · Sep 1984
KEYMED MOBILE ENDOSCOPY PATIENT COUCH
K840920 · Keymed, Inc. · Mar 1984