Cleared Special

K132729 - ISO-GARD MASK

K132729 is an FDA 510(k) clearance for ISO-GARD MASK, manufactured by Teleflexmedical, Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Special 510(k) pathway after a 128-day FDA review.

K132729 · Teleflexmedical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
128d
Days
Class 2
Risk

K132729 is an FDA 510(k) clearance for the ISO-GARD MASK. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on January 9, 2014 after a review of 128 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K132729

510(k) Number K132729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2013
Decision Date January 09, 2014
Days to Decision 128 days
Submission Type Special
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
12d faster than avg
Panel avg: 140d · This submission: 128d
Pathway characteristics
Modification to existing cleared device.

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 25
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K132729.
Dynamic Gas Scavenging System 2 (DGSS - 2)
K193646 · Anesthetic Gas Reclamation, Inc. · Dec 2020
MINISCAV
K160950 · Sedation Systems, LLC · May 2017
ISO-GARD MASK
K142138 · Teleflexmedical, Inc. · Oct 2014
ISO-GARD CLEARAIR MASK
K123176 · Teleflexmedical, Inc. · Feb 2013
ACTIVE WASTE GAS SCAVENGER
K110930 · G. Dundas Co.,Inc. · Jun 2011
VAPOR-CLEAR, MODEL 100
K092031 · Axon Medical, Inc. · Apr 2010