Quantim 16 Autoclave
FDA 510(k) K021064 · Scican
510(k) numberK021064
Submission
- Device name
- Quantim 16 Autoclave
- Applicant
- Scican
Toronto, CA - Received
- April 2, 2002
- Decision date
- August 8, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K214057 | STATIM 6000B Vacuum AutoclaveFLE · Abbreviated | 03/31/2022SE |
| K210326 | Bravo G4 Chamber AutoclaveFLE · Abbreviated | 07/01/2021SE |
| K192910 | STATClave G4 Chamber AutoclaveFLE · Abbreviated | 06/19/2020SE |
| K190062 | STATCLAVE G4 Chamber AutoclaveFLE · Abbreviated | 07/26/2019SE |
| K172292 | SALUS - Hygiene Instrument Reprocessing ContainerKCT · Abbreviated | 11/24/2017SE |
| K132356 | Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40STEGS · Traditional | 01/31/2014SE |
| K112872 | Statim 2000 G4 CassetteFLE · Special | 07/10/2012SE |
| K090937 | E-Statis 40 SystemEBW · Traditional | 07/24/2009SE |
| K090265 | Bravo Autoclave, Models 17, 17V and 21VFLE · Abbreviated | 05/15/2009SE |
| K073319 | Statmatic 31 Handpiece Maintenance UnitEFB · Traditional | 02/04/2008SE |
Questions and answers
When was Quantim 16 Autoclave cleared by the FDA?
Quantim 16 Autoclave (K021064) received a 510(k) decision of Substantially Equivalent on August 8, 2002, 128 days after the submission was received.
What is the product code of K021064?
The FDA product code is FLE – Sterilizer, Steam, a Class II (moderate risk) device regulated under 21 CFR 880.6880.