FRG · Wrap, Sterilization · Chrysalis Intelligence

Device class

Class II

Regulation 880.6850

Total clearances

2020-01-24 → 2026-07-02

Last 12 months

Unique sponsors

Classification details

Medical specialty

General Hospital

Review panel

Regulation number

880.6850

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Wipak OY	7	0	2024-06-07
O&M Halyard, Inc.	4	2	2026-07-02
Turbett Surgical, Inc.	3	0	2025-04-04
Dukal, LLC	2	1	2026-05-28
Plasmapp Co,., Ltd.	2	0	2023-05-09
STERIS Corporation	2	0	2023-08-07
Primed Medical Products, Inc.	2	0	2024-10-07
Medline Industries, LP	2	0	2024-09-17
Andersen Sterilizers, Inc.	2	0	2020-11-12
Wellmed Dental Medical Supply Co., Ltd.	1	0	2025-04-25
Sterileright Packaging Mfg., Inc.	1	0	2021-11-01
Ahlstrom-Munksjo Nonwovens, LLC	1	0	2023-12-07
Comercializadora Brever	1	0	2024-11-04
Weihai Xingtai Packaging Products Co., Ltd.	1	0	2020-04-15
Propper Manufacturing Co., Inc.	1	1	2025-10-31
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	1	0	2022-03-10
Sigma Medical Supplies Corporation	1	0	2021-04-23
Medline Industries, Inc.	1	0	2020-01-24
George Courey, Inc.	1	0	2025-06-06
Wuhan Zonsen Medical Products Co., Ltd.	1	0	2023-08-25
Solidence Surgical Corporation	1	0	2022-08-03
Km Corp.	1	0	2024-09-18
Sterivic Medical Co., Ltd.	1	1	2026-01-28
Kenpax International Limited	1	0	2023-03-23
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.	1	0	2024-10-16

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A4650	HCPCS	Implantable radiation dosimeter, each ✓ CMS-verified description	Medium	Sterilization supplies including sterilization wrap/barriers

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-02	K261897	O&M Halyard, Inc.	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
2026-05-28	K252823	Dukal, LLC	Dukal Crepe Paper Sterilization Wrap
2026-05-18	K253454	O&M Halyard, Inc.	HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap
2026-01-28	K251347	Sterivic Medical Co., Ltd.	Sterilization Pouch/Roll
2025-12-12	K251177	Guangdong Maidi Medical Co., Ltd.	Self-Seal Sterilization Pouch and Roll
2025-10-31	K250306	Propper Manufacturing Co., Inc.	Chex-All Sterilization Pouches and Tubes
2025-06-26	K243179	Yichang Xinxin Paper Products Co., Ltd.	Sterilization Pouch and Roll
2025-06-06	K250321	George Courey, Inc.	GCI Sterilization Wrappers
2025-04-25	K243721	Wellmed Dental Medical Supply Co., Ltd.	Self Sealing Sterilization Pouches
2025-04-04	K250011	Turbett Surgical	Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)
2025-02-24	K241565	Anqing Clean Dental Instrument Technology Co., Ltd.	Sterilization Package/Reel
2025-02-21	K243431	Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.	Medicom Sterilization Pouch and Reel
2025-02-21	K242898	Shanghai Jianzhong Medical Packaging Co., Ltd.	Sterilization Pouches and Reels
2024-11-04	K240438	Comercializadora Brever	CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)
2024-10-16	K242839	Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.	Safe Secure Sterilization Pouches and Rolls
2024-10-07	K242208	Primed Medical Products, Inc.	PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
2024-09-18	K241123	Km Corp.	Perpak Sterilization Tyvek Pouch
2024-09-17	K234132	Medline Industries, LP	Medline Reusable Sterilization Wrappers
2024-09-16	K234050	O&M Halyard, Inc.	HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap
2024-08-07	K240330	O&M Halyard, Inc.	HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
2024-06-21	K240862	Medicom Group, Inc.	Medicom Sterilization Wrap
2024-06-07	K232625	Wipak OY	Steriking® Pouch for Robotic Instruments
2024-05-24	K233777	Primed Medical Products, Inc.	PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
2024-03-22	K233262	Dukal, LLC	Dukal SMS Sterilization Wrap
2023-12-07	K230137	Ahlstrom-Munksjo Nonwovens, LLC	Reliance® Fusion Sterilization Wraps