Cleared Traditional

K112958 - HUMID-VENT HEPA

K112958 is an FDA 510(k) clearance for HUMID-VENT HEPA, manufactured by Teleflex Medical. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K112958 · Teleflex Medical · General Hospital
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Sep 2012
Decision
352d
Days
Class 2
Risk

K112958 is an FDA 510(k) clearance for the HUMID-VENT HEPA. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Teleflex Medical (Durham, US). The FDA issued a Cleared decision on September 21, 2012 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Teleflex Medical devices

FDA 510(k) Submission Details - K112958

510(k) Number K112958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2011
Decision Date September 21, 2012
Days to Decision 352 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 129d · This submission: 352d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 131
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K112958.
HYRDROMAX HMEF
K130664 · A-M Systems · Jun 2013
WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
K121382 · Westmed, Inc. · Dec 2012
FLO-GUARD BREATHING FILTER
K121026 · Intersurgical, Inc. · Nov 2012
MEDISIZE RED AND MEDISIZE BLUE
K110246 · Qserve America, Inc. · Nov 2011
MICROGARD II
K111408 · Carefusion Germany 234 GmbH · Oct 2011
INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
K092451 · Intersurgical, Inc. · Oct 2010