Cleared Traditional

K954801 - TECHFIL

K954801 is an FDA 510(k) clearance for TECHFIL, manufactured by Technimeca Medic, Inc.. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K954801 · Technimeca Medic, Inc. · Anesthesiology device
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Jan 1996
Decision
98d
Days
Class 2
Risk

K954801 is an FDA 510(k) clearance for the TECHFIL. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Technimeca Medic, Inc. (St. Laurent, Quebec, CA). The FDA issued a Cleared decision on January 25, 1996 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Technimeca Medic, Inc. devices

FDA 510(k) Submission Details - K954801

510(k) Number K954801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1995
Decision Date January 25, 1996
Days to Decision 98 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
42d faster than avg
Panel avg: 140d · This submission: 98d
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 K954801.
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
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