Cleared Traditional

K123176 - ISO-GARD CLEARAIR MASK

K123176 is an FDA 510(k) clearance for ISO-GARD CLEARAIR MASK, manufactured by Teleflexmedical, Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K123176 · Teleflexmedical, Inc. · Anesthesiology device
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Feb 2013
Decision
127d
Days
Class 2
Risk

K123176 is an FDA 510(k) clearance for the ISO-GARD CLEARAIR MASK. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on February 14, 2013 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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 Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K123176

510(k) Number K123176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2012
Decision Date February 14, 2013
Days to Decision 127 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 140d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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 - CBN Apparatus, Gas-scavenging

All 13
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K123176.
Dynamic Gas Scavenging System 2 (DGSS - 2)
K193646 · Anesthetic Gas Reclamation, Inc. · Dec 2020
ISO-GARD MASK
K142138 · Teleflexmedical, Inc. · Oct 2014
ISO-GARD MASK
K132729 · Teleflexmedical, Inc. · Jan 2014
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532 · Medipart Jerry Alexander · Aug 1989
OPEN RESERVOIR SCAVENGER
K864034 · Draeger Medical, Inc. · Dec 1986
GAS EVACUATION ACCESSORY
K852772 · Siemens Elema AB · Oct 1985