Cleared Traditional

DRAGER DVE 4000 SERIES SYSTEM (K921297) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K921297 · Alm Surgical Equipment, Inc. · General & Plastic Surgery device
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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

Submission Details

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.

Device Classification

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.