Cleared Traditional

K921297 - DRAGER DVE 4000 SERIES SYSTEM

K921297 is an FDA 510(k) clearance for DRAGER DVE 4000 SERIES SYSTEM, manufactured by Alm Surgical Equipment, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K921297 · Alm Surgical Equipment, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
255d
Days
Class 1
Risk

K921297 is an FDA 510(k) clearance for the DRAGER DVE 4000 SERIES SYSTEM. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Alm Surgical Equipment, Inc. (Santa Ana, US). The FDA issued a Cleared decision on November 27, 1992 after a review of 255 days - an extended review 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: 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 Alm Surgical Equipment, Inc. devices

FDA 510(k) Submission Details - K921297

510(k) Number K921297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1992
Decision Date November 27, 1992
Days to Decision 255 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
140d slower than avg
Panel avg: 115d · This submission: 255d
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 K921297.
AMSCO SURGICAL TABLE
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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