Cleared Traditional

Halyard ONE-STEP* Sterilization Wrap (K192147) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192147 · Owens & Minor (O&M) Halyard, Inc. · General Hospital
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Oct 2019
Decision
63d
Days
Class 2
Risk

K192147 is an FDA 510(k) clearance for the Halyard ONE-STEP* Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Owens & Minor (O&M) Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on October 10, 2019 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Owens & Minor (O&M) Halyard, Inc. devices

Submission Details

510(k) Number K192147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2019
Decision Date October 10, 2019
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 Consultant

Peter R Kalkbrenner Sterilucent, Inc.
Peter Kalkbrenner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRG Wrap, Sterilization

All 89
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K192147.
Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
K193561 · Weihai Xingtai Packaging Products Co., Ltd. · Apr 2020
Gemini Titan Sterilization Wrap
K192641 · Medline Industries, Inc. · Jan 2020
Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
K182184 · Mdk (Shanghai) Medical Packing Co., Ltd. · Oct 2019
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
K183356 · Weihai Xingtai Packaging Products Co., Ltd. · Aug 2019
Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
K181957 · Tianchang Jiarui Packaging Material Co., Ltd. · Jul 2019
JAMBRO Single Core A Sterilization wrap
K182656 · Jiangsu Zhande Medical Supplies Co., Ltd. · Jun 2019