Cleared Traditional

K953980 - KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT

K953980 is an FDA 510(k) clearance for KREUZER CEILING MOUNTED SUPPORT SYSTEMS, manufactured by Kreuzer Corp.. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K953980 · Kreuzer Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
85d
Days
Class 1
Risk

K953980 is an FDA 510(k) clearance for the KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Kreuzer Corp. (Murfreesboro, US). The FDA issued a Cleared decision on November 16, 1995 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kreuzer Corp. devices

FDA 510(k) Submission Details - K953980

510(k) Number K953980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1995
Decision Date November 16, 1995
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
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 18
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K953980.
DRAGER GEMINA WALL-MOUNTED WORKPLACE
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TELETOM
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SKYTRON SKYBOOM SERIES
K950192 · Skytron, Div. the Kmw Group, Inc. · Apr 1995
RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES
K926463 · Midmark Corp. · Oct 1994
IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE
K942486 · Mdt Corp., Inc. · Aug 1994