Cleared Traditional

K952083 - TEC IV AND TEC V ANESTHESIA VAPORIZERS ...

K952083 is the FDA 510(k) clearance for TEC IV AND TEC V ANESTHESIA VAPORIZERS ... by Clover Medical Equipment Services, Inc.. It is a Class 2 Anesthesiology device (product code CAD) cleared through the Traditional 510(k) pathway after a 537-day FDA review.

K952083 · Clover Medical Equipment Services, Inc. · Anesthesiology device
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Oct 1996
Decision
537d
Days
Class 2
Risk

K952083 is an FDA 510(k) clearance for the TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Clover Medical Equipment Services, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 21, 1996 after a review of 537 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5880 - the FDA anesthesiology and respiratory 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Clover Medical Equipment Services, Inc. devices

Submission Details

510(k) Number K952083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1995
Decision Date October 21, 1996
Days to Decision 537 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
397d slower than avg
Panel avg: 140d · This submission: 537d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAD Vaporizer, Anesthesia, Non-heated

All 15
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K952083.
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K981472 · Draeger Medical, Inc. · May 1998
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K973051 · Draeger Medical, Inc. · Oct 1997
DRAGER-VAPOR 2000
K971923 · Draeger Medical, Inc. · Sep 1997
OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE
K942091 · Ohmeda Medical · Mar 1995
OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER
K913593 · Ohmeda Medical · Oct 1992
OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
K892057 · Ohmeda Medical · Apr 1989