Cleared Traditional

K132709 - VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER

K132709 is an FDA 510(k) clearance for VR MEDICAL HEAT AND MOISTURE EXCHANGER ..., manufactured by Vr Medical. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K132709 · Vr Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
335d
Days
Class 2
Risk

K132709 is an FDA 510(k) clearance for the VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Vr Medical (Kunshan, CN). The FDA issued a Cleared decision on July 30, 2014 after a review of 335 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 Vr Medical devices

FDA 510(k) Submission Details - K132709

510(k) Number K132709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2013
Decision Date July 30, 2014
Days to Decision 335 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
206d slower than avg
Panel avg: 129d · This submission: 335d
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 147
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K132709.
ThermoShield HME Filter
K163300 · Flexicare Medical Limited. · Mar 2017
Breathing circuit bacterial/viral filter
K151498 · Zhejiang Haisheng Medical Device Co., Ltd. · Dec 2015
INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
K141087 · Intersurgical Incorporated · Feb 2015
AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
K132679 · Galemed Corp. · Apr 2014
EXCELERON BACTERIAL FILTERS
K131626 · Exceleron Medical · Feb 2014
RT016 INSPIRATORY FILTER
K133666 · Fisher &Paykel Healthcare , Ltd. · Feb 2014