Cleared Traditional

K955750 - TELETOM

K955750 is an FDA 510(k) clearance for TELETOM, manufactured by Berchtold Holding GmbH. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K955750 · Berchtold Holding GmbH · General & Plastic Surgery device
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Feb 1996
Decision
52d
Days
Class 1
Risk

K955750 is an FDA 510(k) clearance for the TELETOM. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Berchtold Holding GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on February 8, 1996 after a review of 52 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.

FDA 510(k) Submission Details - K955750

510(k) Number K955750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date February 08, 1996
Days to Decision 52 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 115d · This submission: 52d
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 25
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K955750.
TENET RADIOLUCENT HAND TABLE
K963506 · Tenet Medical Engineering · Jan 1997
DRAGER GEMINA WALL-MOUNTED WORKPLACE
K961886 · Alm Surgical Equipment, Inc. · Jul 1996
DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM
K961742 · Alm Surgical Equipment, Inc. · Jul 1996
KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT
K953980 · Kreuzer Corp. · Nov 1995
LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY
K951854 · Leonard Medical, Inc. · Jun 1995
SKYTRON SKYBOOM SERIES
K950192 · Skytron, Div. the Kmw Group, Inc. · Apr 1995
K955750 · TELETOM
Download PDF Berchtold Holding GmbH