Cleared Traditional

K940068 - STRYKER OPERATING ROOM TABLE

K940068 is an FDA 510(k) clearance for STRYKER OPERATING ROOM TABLE, manufactured by Stryker Medical. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K940068 · Stryker Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
119d
Days
Class 1
Risk

K940068 is an FDA 510(k) clearance for the STRYKER OPERATING ROOM TABLE. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on May 5, 1994 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Medical devices

FDA 510(k) Submission Details - K940068

510(k) Number K940068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1994
Decision Date May 05, 1994
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

FQO Device Classification - Class 1, General Controls

Product Code FQO Table, Operating-room, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FQO Table, Operating-room, Ac-powered

All 8
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K940068.
STERIS CMAX XLT SURGICAL TABLE
K090136 · STERIS Corporation · Mar 2009
AMSCO SURGICAL TABLE
K971307 · STERIS Corporation · Jun 1997
RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES
K926463 · Midmark Corp. · Oct 1994
QUANTUM 3080 SURGICAL TABLE
K930493 · American Sterilizer Co. · Jun 1993
712 PLASTIC SURGERY TABLE & ACCESORIES
K915141 · Midmark Corp. · Jan 1992
GENERAL SURGICAL TABLE AND ACCESSORIES
K882660 · American Sterilizer Co. · Jul 1988