Cleared Traditional

K112958 - HUMID-VENT HEPA

K112958 is the FDA 510(k) clearance for HUMID-VENT HEPA by Teleflex Medical. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 55
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K112958.
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RT016 INSPIRATORY FILTER
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RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · Fisher &Paykel Healthcare , Ltd. · Aug 2005
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
K043120 · Datex-Ohmeda, Inc. · Mar 2005
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
K030990 · Datex-Ohmeda · Jun 2003