Cleared Traditional

K935297 - STRYKER AMBULANCE COT MODEL 6060

K935297 is an FDA 510(k) clearance for STRYKER AMBULANCE COT MODEL 6060, manufactured by Stryker Medical. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K935297 · Stryker Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
108d
Days
Class 2
Risk

K935297 is an FDA 510(k) clearance for the STRYKER AMBULANCE COT MODEL 6060. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on February 18, 1994 after a review of 108 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 Stryker Medical devices

FDA 510(k) Submission Details - K935297

510(k) Number K935297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date February 18, 1994
Days to Decision 108 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
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 12
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K935297.
HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER
K952447 · Hill-Rom, Inc. · Nov 1995
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