Cleared Traditional

SHOWER CHAIRS (K895740) - FDA 510(k) Clearance

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

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895740 · Lumex, Inc. · General Hospital
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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

Submission Details

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.

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.