Cleared Traditional

K895740 - SHOWER CHAIRS

Also marketed or referenced as:
BED/STRETCHER LINEN & UTILITY CART

K895740 is an FDA 510(k) clearance for SHOWER CHAIRS, manufactured by Lumex, Inc.. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K895740 · Lumex, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
149d
Days
Class 2
Risk

K895740 is an FDA 510(k) clearance for the SHOWER CHAIRS. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Lumex, Inc. (Bay Shore, US). The FDA issued a Cleared decision on February 22, 1990 after a review of 149 days - within the typical 510(k) review window.

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 Lumex, Inc. devices

FDA 510(k) Submission Details - K895740

510(k) Number K895740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date February 22, 1990
Days to Decision 149 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 129d · This submission: 149d
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 16
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K895740.
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
KEYMED OFFICE COUCH
K854304 · Keymed, Inc. · Nov 1985
THE KEYMED VARI-HEIGHT PATIENT COUCH
K853421 · Keymed, Inc. · Sep 1985
CENTURIAN HYDRAULIC STRETCHER
K843439 · American Sterilizer Co. · Sep 1984