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
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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.

View all Teleflexmedical, Inc. devices

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 13
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K132729.
Nitronox Scavenger Plus
K223452 · Parker Hannifin Corporation · Mar 2023
Dynamic Gas Scavenging System 2 (DGSS - 2)
K193646 · Anesthetic Gas Reclamation, Inc. · Dec 2020
ISO-GARD MASK
K142138 · Teleflexmedical, Inc. · Oct 2014
ISO-GARD CLEARAIR MASK
K123176 · Teleflexmedical, Inc. · Feb 2013
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532 · Medipart Jerry Alexander · Aug 1989
OPEN RESERVOIR SCAVENGER
K864034 · Draeger Medical, Inc. · Dec 1986