Chrysalis Intelligence · Product Codes · MLR

MLR · Sterilizer, Chemical

General Hospital · 14 clearances · 5 unique sponsors

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Device class

Class II

Regulation 880.6860

Total clearances

14

2021-10-09 → 2026-04-15

Last 12 months

1

Unique sponsors

5

Classification details

Medical specialty

General Hospital

Review panel

HO

Regulation number

880.6860

Implant

N

Life-sustain / support

N

GMP exempt

N

Third-party review

Y

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Advanced Sterilization Products, Inc.	5	1	2026-04-15
Plasmapp Co,., Ltd.	4	0	2023-05-25
Steris	3	0	2023-10-20
Ideate Medical, Inc.	1	0	2024-06-27
Lowtem Co., Ltd.	1	0	2024-09-18

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	Supplies for use with external patient-controlled analgesia infusion pump; chemical sterilizer supply code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-15	K252843	Advanced Sterilization Products, Inc.	STERRAD 100NX Sterilization System with ALLClear Technology (10104)
2025-04-14	K250802	Advanced Sterilization Products, Inc.	STERRAD® 100NX Sterilizer with ALLClear Technology (10104)
2024-09-18	K231893	Lowtem Co., Ltd.	LOWTEM Crystal 120
2024-07-05	K234082	Advanced Sterilization Products	STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077)
2024-06-27	K233762	Ideate Medical, Inc.	SteroScope® Sterilization Technology System
2023-10-20	K233065	Steris	V-PRO maX 2 Low Temperature Sterilization System
2023-08-07	K223476	STERIS Corporation	V-PRO maX 2 Low Temperature Sterilization System
2023-05-25	K231169	Plasmapp Co,., Ltd.	STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
2023-05-09	K223015	Plasmapp Co,., Ltd.	STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette
2023-04-14	K220345	Plasmapp Co,., Ltd.	STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
2022-09-09	K222093	Steris	V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System
2022-05-16	K220404	Advanced Sterilization Products, Inc.	STERRAD NX with ALLClear Technology
2021-10-22	K212200	Plasmapp Co,., Ltd.	STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
2021-10-09	K212174	Advanced Sterilization Products, Inc.	STERRAD 100NX Sterilizer with ALLClear Technology