Cleared Traditional

K172280 - BH Sterilization Pouch

K172280 is the FDA 510(k) clearance for BH Sterilization Pouch by Bh Medical Products Co., Ltd.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K172280 · Bh Medical Products Co., Ltd. · General Hospital
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Aug 2018
Decision
371d
Days
Class 2
Risk

K172280 is an FDA 510(k) clearance for the BH Sterilization Pouch. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Bh Medical Products Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on August 3, 2018 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Bh Medical Products Co., Ltd. devices

Submission Details

510(k) Number K172280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2017
Decision Date August 03, 2018
Days to Decision 371 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
242d slower than avg
Panel avg: 129d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - FRG Wrap, Sterilization

All 118
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K172280.
Safe Secure Sterilization Pouches and Rolls
K180139 · Safe Secure Packing Co., Ltd. · Jan 2019
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K183297 · STERIS Corporation · Jan 2019
Cardinal Health Sterilization Wrap
K181174 · Cardinal Health200, LLC · Dec 2018
Sterilization Pouch/Roll Made with Tyvek
K180672 · Sigma Medical Supplies Corporation · Jun 2018
SIGMA Sterilization Pouch and Roll
K180661 · Sigma Medical Supplies Corp. · Jun 2018
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K172749 · STERIS Corporation · Feb 2018