Cleared Traditional

K921626 - TELETOM(R)

K921626 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 29-day FDA review.

K921626 · Berchtold Holding GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
29d
Days
Class 1
Risk

K921626 is an FDA 510(k) clearance for the TELETOM(R). 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 May 5, 1992 after a review of 29 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 Berchtold Holding GmbH devices

FDA 510(k) Submission Details - K921626

510(k) Number K921626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date May 05, 1992
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 13
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K921626.
IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE
K942486 · Mdt Corp., Inc. · Aug 1994
ENDEX ENDOSCOPIC POSITIONING SYSTEM
K936308 · Andronic Devices, Ltd. · Mar 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
CEILING MOUNTED SUPPORT
K831086 · Amsco Co. · Aug 1983