Cleared Traditional

K952083 - TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE

K952083 is an FDA 510(k) clearance for TEC IV AND TEC V ANESTHESIA VAPORIZERS ..., manufactured by Clover Medical Equipment Services, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K952083

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
Combination Product No
PCCP Authorized No
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.

CAD Device Classification - Class 2, Special Controls

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 33
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
QUIK-FIL VAPORIZER KEYED FILLER
K961468 · Penlon , Ltd. · Jul 1996
PPV VAPORIZER (MODIFICATION)
K960944 · Penlon , Ltd. · Apr 1996
TECHNOFIL
K953748 · Technimeca Medic, Inc. · Jan 1996