FLE · Sterilizer, Steam
General Hospital · 21 CFR 880.6880 · Class 2
Overview
| Product Code | FLE |
|---|---|
| Device Name | Sterilizer, Steam |
| Regulation | 21 CFR 880.6880 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 184)
Showing 20 most recent of 184 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260254 | Enbio PRO | Enbio Group AG | Feb 26, 2026 | SESE |
| K252307 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | Jan 22, 2026 | SESE |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | Dec 30, 2025 | SESE |
| K250164 | Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co., Ltd. | Aug 14, 2025 | SESE |
| K243994 | Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. | Jun 6, 2025 | SESE |
| K243801 | FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC | Mar 7, 2025 | SESE |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation | Apr 4, 2024 | SESE |
| K233504 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | Feb 8, 2024 | SESE |
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | Dec 19, 2023 | SESE |
| K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | Nov 27, 2023 | SESE |
| K232485 | AMSCO 600 Steam Sterilizer | Steris | Sep 13, 2023 | SESE |
| K231489 | Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. | Jun 21, 2023 | SESE |
| K223858 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | May 5, 2023 | SESE |
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | Feb 10, 2023 | SESE |
| K213545 | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | Steelco S.P.A. | Feb 2, 2023 | SESE |
| K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | Tuttnauer , Ltd. | Dec 16, 2022 | SESE |
| K220102 | MOST-T Autoclave | Shinva Medical Instrument Co., Ltd. | Oct 12, 2022 | SESE |
| K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | Tuttnauer , Ltd. | Sep 20, 2022 | SESE |
| K213758 | Lexa PLUS RIS-311 | W&H Sterilization S.R.L. | Aug 19, 2022 | SESE |
| K220736 | Consolidated HC Steam Sterilizer | Consolidated Machine Corp. | Aug 1, 2022 | SESE |
Top Applicants
- STERIS Corporation — 21 clearances
- Tuttnauer U.S.A Co, Ltd. — 8 clearances
- Midmark Corp. — 7 clearances
- Scican , Ltd. — 7 clearances
- Getinge/Castle, Inc. — 6 clearances
