Sterilizer, Series 3000, Modification to
FDA 510(k) K770682 · Castle Co.
510(k) numberK770682
Submission
- Device name
- Sterilizer, Series 3000, Modification to
- Applicant
- Castle Co.
Mchenry, IL, US - Received
- April 11, 1977
- Decision date
- May 20, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLE – Sterilizer, Steam
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6880
- Specialty
- General Hospital
Other 510(k)s with product code FLE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261055 | AMSCO 700 Steam SterilizerFLE · Traditional | STERIS Corporation | 06/24/2026SE |
| K260254 | Enbio PROFLE · Traditional | Enbio Group AG | 02/26/2026SE |
| K252307 | Getinge GSS67N Series Steam SterilizerFLE · Traditional | Maquet GmbH (A Getinge Group Company) | 01/22/2026SE |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam SterilizerFLE · Traditional | Lucas Lifecare | 12/30/2025SE |
| K250164 | Cassette Autoclave (ACA5)FLE · Traditional | Guangzhou Ajax Medical Equipment Co., Ltd. | 08/14/2025SE |
| K243994 | Steam Sterilizer (2545D)FLE · Traditional | Ningbo Ican Machines Co., Ltd. | 06/06/2025SE |
| K243801 | FRONT-LINE Field Sterilizer (FL135)FLE · Special | Fort Defiance Industries, LLC | 03/07/2025SE |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerFLE · Traditional | Midmark Corporation | 04/04/2024SE |
| K233504 | Lexa MINI (RIS-303, RIS-305)FLE · Traditional | W&H Sterilization S.R.L. | 02/08/2024SE |
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)FLE · Abbreviated | Primus Sterilizer Company, LLC | 12/19/2023SE |
More from Primus Sterilizer Company, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K870975 | Modified Castle PowerclaveFLE · Traditional | 04/17/1987SE |
| K860263 | Castle 7538 Floor Loading WasherLDS · Traditional | 03/05/1986SE |
| K844089 | Castle 7515 Utensil/Glassware WasherLDS · Traditional | 01/14/1985SE |
| K834048 | Bovie Conductive Adhes-Disper-ElectroGEI · Traditional | 04/04/1984SE |
| K833074 | Castle Tec-Test S.M.A.R.T. PackJOJ · Traditional | 11/07/1983SE |
| K831595 | Castle Model 3341 & 3441 & 4141 Gas AerFLI · Traditional | 06/15/1983SE |
| K792660 | 1500 Eo Exhaust HoodFLF · Traditional | 01/29/1980SE |
| K792649 | Unispore-Biological IndicatorsFRC · Traditional | 01/29/1980SE |
| K790677 | Eo Evacuating System IFLI · Traditional | 05/07/1979SE |
| K781887 | 9100 Daystar and 9110 Orbiter PackageFSY · Traditional | 12/12/1978SE |
Questions and answers
When was Sterilizer, Series 3000, Modification to cleared by the FDA?
Sterilizer, Series 3000, Modification to (K770682) received a 510(k) decision of Substantially Equivalent on May 20, 1977, 39 days after the submission was received.
What is the product code of K770682?
The FDA product code is FLE – Sterilizer, Steam, a Class II (moderate risk) device regulated under 21 CFR 880.6880.