Cleared Traditional

K261897 - HALYARD* ARMOR-FLEX* Sterilization Wrap...

Also marketed or referenced as:
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

K261897 is the FDA 510(k) clearance for HALYARD* ARMOR-FLEX* Sterilization Wrap... by O&M Halyard, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K261897 · O&M Halyard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
27d
Days
Class 2
Risk

K261897 is an FDA 510(k) clearance for the HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 2, 2026 after a review of 27 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 O&M Halyard, Inc. devices

Submission Details

510(k) Number K261897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2026
Decision Date July 02, 2026
Days to Decision 27 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 119
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K261897.
Dukal Crepe Paper Sterilization Wrap
K252823 · Dukal, LLC · May 2026
HALYARD* ONE-STEP* Sterilization Wrap
K253454 · O&M Halyard, Inc. · May 2026
Sterilization Pouch/Roll
K251347 · Sterivic Medical Co., Ltd. · Jan 2026
Self-Seal Sterilization Pouch and Roll
K251177 · Guangdong Maidi Medical Co., Ltd. · Dec 2025
Chex-All Sterilization Pouches and Tubes
K250306 · Propper Manufacturing Co., Inc. · Oct 2025
Sterilization Pouch and Roll
K243179 · Yichang Xinxin Paper Products Co., Ltd. · Jun 2025