Cleared Traditional

K933071 - STS 701 TRANSPORT STRETCHER

K933071 is an FDA 510(k) clearance for STS 701 TRANSPORT STRETCHER, manufactured by Wy'East Medical Corp.. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K933071 · Wy'East Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
218d
Days
Class 2
Risk

K933071 is an FDA 510(k) clearance for the STS 701 TRANSPORT STRETCHER. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Wy'East Medical Corp. (Clackamas, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 218 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 Wy'East Medical Corp. devices

FDA 510(k) Submission Details - K933071

510(k) Number K933071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date January 26, 1994
Days to Decision 218 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 129d · This submission: 218d
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 17
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K933071.
EMERGENCY/ACCIDENT TROLLEY 550
K946101 · Hogan & Hartson · Feb 1995
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
GENERAL PROCEDURAL STRETCHERS (P880- P886)
K922809 · Hill-Rom, Inc. · Mar 1993
MODEL #527 OPHTHALMIC STRETCHER
K904011 · Midmark Corp. · Oct 1990