SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA
FDA 510(k) clearance K120149 · decided 2012-05-08
Clearance details
- K-number
- K120149
- Device name
- SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA
- Applicant
- Sakura Seiki Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-18
- Decision date
- 2012-05-08
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- FLE
- Device class
- 2
- Regulation number
- 880.6880
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Great Neck, NY, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sakura Seiki Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMSCO 700 Steam Sterilizer (K261055) | STERIS Corporation | 2026-06-24 |
| Enbio PRO (K260254) | Enbio Group AG | 2026-02-26 |
| Getinge GSS67N Series Steam Sterilizer (K252307) | Maquet GmbH (A Getinge Group Company) | 2026-01-22 |
| Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (K250168) | Lucas Lifecare | 2025-12-30 |
| Cassette Autoclave (ACA5) (K250164) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2025-08-14 |
| Steam Sterilizer (2545D) (K243994) | Ningbo Ican Machines Co., Ltd. | 2025-06-06 |
| FRONT-LINE Field Sterilizer (FL135) (K243801) | Fort Defiance Industries, LLC | 2025-03-07 |
| Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (K233026) | Midmark Corporation | 2024-04-04 |
| Lexa MINI (RIS-303, RIS-305) (K233504) | W&H Sterilization S.R.L. | 2024-02-08 |
| PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (K233132) | Primus Sterilizer Company, LLC | 2023-12-19 |
| T-Top 10 & T-Top T-Top 11 (K232658) | Tuttnauer U.S.A Co, Ltd. | 2023-11-27 |
| AMSCO 600 Steam Sterilizer (K232485) | Steris | 2023-09-13 |
Recalls involving this device
No recalls on record reference this clearance.