Cleared Traditional

K922809 - GENERAL PROCEDURAL STRETCHERS (P880- P886)

K922809 is an FDA 510(k) clearance for GENERAL PROCEDURAL STRETCHERS (P880- P886), manufactured by Hill-Rom, Inc.. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K922809 · Hill-Rom, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
294d
Days
Class 2
Risk

K922809 is an FDA 510(k) clearance for the GENERAL PROCEDURAL STRETCHERS (P880- P886). Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 294 days - an extended review 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: 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 Hill-Rom, Inc. devices

FDA 510(k) Submission Details - K922809

510(k) Number K922809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1992
Decision Date March 31, 1993
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 129d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPO Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K922809.
STRYKER POWERED STRETCHER
K942948 · Stryker Corp. · Jan 1995
MODEL 561 C-ARM PROCEDURES STRETCHER
K923730 · Midmark Corp. · Feb 1994
HILL-ROM VIA STRETCHER (P1300 - P1303)
K922808 · Hill-Rom, Inc. · Mar 1993
MODEL #527 OPHTHALMIC STRETCHER
K904011 · Midmark Corp. · Oct 1990
KEYMED OFFICE COUCH
K854304 · Keymed, Inc. · Nov 1985
THE KEYMED VARI-HEIGHT PATIENT COUCH
K853421 · Keymed, Inc. · Sep 1985