FLE · Sterilizer, Steam · Chrysalis Intelligence

Device class

Class II

Regulation 880.6880

Total clearances

2020-06-19 → 2026-06-24

Last 12 months

Unique sponsors

Classification details

Medical specialty

General Hospital

Review panel

Regulation number

880.6880

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
Steris	5	1	2026-06-24
Enbio Group AG	3	1	2026-02-26
Scican , Ltd.	3	0	2022-03-31
Tuttnauer , Ltd.	3	0	2022-12-16
W&H Sterilization S.R.L.	3	0	2024-02-08
Maquet GmbH	2	0	2022-05-18
Fort Defiance Industries, LLC	2	0	2025-03-07
Primus Sterilizer Company, LLC	2	0	2023-12-19
Tuttnauer U.S.A Co, Ltd.	1	0	2023-11-27
Steelco S.P.A.	1	0	2023-02-02
Midmark Corporation	1	0	2024-04-04
Guangzhou Ajax Medical Equipment Co., Ltd.	1	0	2025-08-14
Sturdy Industrial Co., Ltd.	1	0	2023-06-21
Ningbo Ican Machines Co., Ltd.	1	0	2025-06-06
Maquet GmbH (A Getinge Group Company)	1	1	2026-01-22
Lucas Lifecare	1	1	2025-12-30
Shinva Medical Instrument Co., Ltd.	1	0	2022-10-12
Consolidated Machine Corp.	1	0	2022-08-01

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
E1930	HCPCS	—	Medium	Sterilizer, steam, general hospital equipment supply code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-24	K261055	STERIS Corporation	AMSCO 700 Steam Sterilizer
2026-02-26	K260254	Enbio Group AG	Enbio PRO
2026-01-22	K252307	Maquet GmbH (A Getinge Group Company)	Getinge GSS67N Series Steam Sterilizer
2025-12-30	K250168	Lucas Lifecare	Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
2025-08-14	K250164	Guangzhou Ajax Medical Equipment Co., Ltd.	Cassette Autoclave (ACA5)
2025-06-06	K243994	Ningbo Ican Machines Co., Ltd.	Steam Sterilizer (2545D)
2025-03-07	K243801	Fort Defiance Industries, LLC	FRONT-LINE Field Sterilizer (FL135)
2024-04-04	K233026	Midmark Corporation	Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
2024-02-08	K233504	W&H Sterilization S.R.L.	Lexa MINI (RIS-303, RIS-305)
2023-12-19	K233132	Primus Sterilizer Company, LLC	PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
2023-11-27	K232658	Tuttnauer U.S.A Co, Ltd.	T-Top 10 & T-Top T-Top 11
2023-09-13	K232485	Steris	AMSCO 600 Steam Sterilizer
2023-06-21	K231489	Sturdy Industrial Co., Ltd.	Sturdy Autoclave Super Microm
2023-05-05	K223858	W&H Sterilization S.R.L.	Lexa MINI (RIS-303, RIS-305)
2023-02-10	K221474	Primus Sterilizer Company, LLC	PRIMUS Healthcare Sterilizer (Model PSS11-HC)
2023-02-02	K213545	Steelco S.P.A.	Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
2022-12-16	K222608	Tuttnauer , Ltd.	Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
2022-10-12	K220102	Shinva Medical Instrument Co., Ltd.	MOST-T Autoclave
2022-09-20	K221227	Tuttnauer , Ltd.	Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
2022-08-19	K213758	W&H Sterilization S.R.L.	Lexa PLUS RIS-311
2022-08-01	K220736	Consolidated Machine Corp.	Consolidated HC Steam Sterilizer
2022-05-18	K214120	Maquet GmbH	GSS610N21 Series Steam Sterilizer
2022-03-31	K214057	Scican , Ltd.	STATIM 6000B Vacuum Autoclave
2022-03-02	K213457	Fort Defiance Industries, LLC	Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135
2022-02-22	K213991	Enbio Group AG	Enbio S