Cleared Traditional

K151498 - Breathing circuit bacterial/viral filter

K151498 is the FDA 510(k) clearance for Breathing circuit bacterial/viral filter by Zhejiang Haisheng Medical Device Co., Ltd.. It is a Class 2 General Hospital device (product code CAH) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K151498 · Zhejiang Haisheng Medical Device Co., Ltd. · General Hospital
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Dec 2015
Decision
197d
Days
Class 2
Risk

K151498 is an FDA 510(k) clearance for the Breathing circuit bacterial/viral filter. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Zhejiang Haisheng Medical Device Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on December 18, 2015 after a review of 197 days - an extended review cycle.

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. Standard predicate reliance. 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 Zhejiang Haisheng Medical Device Co., Ltd. devices

Submission Details

510(k) Number K151498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2015
Decision Date December 18, 2015
Days to Decision 197 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 129d · This submission: 197d
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 60
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K151498.
Altera Filter and HME/Filter
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HUMID-VENT HEPA
K112958 · Teleflex Medical · Sep 2012
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · Fisher &Paykel Healthcare , Ltd. · Aug 2005