Data / Medical devices / Israel / Tuttnauer Ltd.
Tuttnauer Ltd.: FDA-registered device maker in BEIT SHEMESH Jerusalem, Israel, 17 510(k) clearances
Tuttnauer Ltd. is registered with the FDA (registration 8030087) in BEIT SHEMESH Jerusalem, Israel. It lists 5 device types. The FDA files 17 510(k) clearances under its listings, the newest dated November 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8030087
- FEI number
- 3005343391
- Address
- Har-Tuv Industrial Zone Box 170, BEIT SHEMESH Jerusalem, Israel, 9910101
- Owner or operator
- TUTTNAUER LTD. (8030087)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 7, 2007
- Registered through
- 2026
- Brand names listed
- 1730, 2340, 2540, 3870 - E, 1730, 2340, 2540, 3870 E/EK/EP, EZ9, EZ10, 3870 E/M, 2340, 2540, 3870 EA/EKA, 3870HSG and 3870HSG-WS, 4472, 5596, 6690, 66120, 69150, 6990, 69120, 69180, ELARA11, ELARAII, EZ9, EZ11, EZ15 - PLUS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Pasteurization, Hot Water | LDS | 2 | Specification developer | accessdata.fda.gov |
| Indicator, Biological Sterilization Process | FRC | 2 | Specification developer | accessdata.fda.gov |
| Indicator, Chemical, Enzymatic, Sterilization Process | MTC | 2 | Specification developer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Specification developer | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2023 | K232658 | T-Top 10 & T-Top T-Top 11 | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| December 16, 2022 | K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | FLE | Substantially Equivalent | Tuttnauer , Ltd. | accessdata.fda.gov |
| January 4, 2022 | K213080 | T-Edge 10, T-Edge 11 | FLE | Substantially Equivalent | Tuttnauer , Ltd. | accessdata.fda.gov |
| December 14, 2021 | K210481 | Instant 20s Indicator | MTC | Substantially Equivalent | True Indicating, LLC | accessdata.fda.gov |
| June 30, 2020 | K200272 | Terragene Chemdye | JOJ | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| September 13, 2019 | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | FRC | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| July 8, 2019 | K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | FLE | Substantially Equivalent | Tuttnauer , Ltd. | accessdata.fda.gov |
| November 2, 2017 | K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator | FRC | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| January 15, 2015 | K143311 | Pre-vacuum Tabletop Autoclave | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| December 8, 2011 | K111736 | TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
| August 20, 2009 | K090783 | TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| February 2, 2007 | K063711 | TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
| August 12, 2004 | K032192 | PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| February 9, 2001 | K993856 | TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| October 29, 1997 | K973550 | TUTTNAUER TABLE-TOP AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| July 8, 1993 | K920478 | TUTTNAUER LSI (AUTOMATIC) | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
| January 11, 1984 | K833837 | AMERICAN GOLD SERIES AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilizer, Steam
- All makers of Indicator, Biological Sterilization Process
- All makers of Device, Pasteurization, Hot Water
- All makers of Indicator, Physical/Chemical Sterilization Process
Updated November 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.