Product code FRG: 510(k) clearances and predicates

Product code FRG covers HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology. FDA lists 323 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.

Clearance volume

323 clearances on file under product code FRG. Counts by year:

Year	Clearances
2022	9
2023	9
2024	11
2025	9
2026 so far	4

Recent clearances

Newest FRG clearances in the FDA index, with applicant and decision date:

• K261897, HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology, applicant O&M Halyard, Inc., decided 2026-07-02. FDA record
• K252823, Dukal Crepe Paper Sterilization Wrap, applicant Dukal, LLC, decided 2026-05-28. FDA record
• K253454, HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap, applicant O&M Halyard, Inc., decided 2026-05-18. FDA record
• K251347, Sterilization Pouch/Roll, applicant Sterivic Medical Co., Ltd., decided 2026-01-28. FDA record
• K251177, Self-Seal Sterilization Pouch and Roll, applicant Guangdong Maidi Medical Co., Ltd., decided 2025-12-12. FDA record
• K250306, Chex-All Sterilization Pouches and Tubes, applicant Propper Manufacturing Co., Inc., decided 2025-10-31. FDA record
• K243179, Sterilization Pouch and Roll, applicant Yichang Xinxin Paper Products Co., Ltd., decided 2025-06-26. FDA record
• K250321, GCI Sterilization Wrappers, applicant George Courey, Inc., decided 2025-06-06. FDA record

What this means for a regulatory watcher

Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Dukal Crepe Paper Sterilization Wrap, HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap. Watch new FRG clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.

FAQ

What is FDA product code FRG?

It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FRG clearances include HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology.

How many 510(k) clearances use product code FRG?

323 at the time this page was generated, from openFDA records.

How do I find a predicate device under FRG?

Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.

How do I track new FRG clearances?

Get 510(k) alerts filtered to this product code and read each new clearance as it posts.

Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.