Cleared Traditional

K172280 - BH Sterilization Pouch

K172280 is an FDA 510(k) clearance for BH Sterilization Pouch, manufactured by Bh Medical Products Co., Ltd.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K172280

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.

FRG Device Classification - Class 2, Special Controls

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 226
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