# Tuttnauer Co., Ltd.

- Location (FDA's records): Beit-Shemesh, IL
- FDA decisions: 10 (1984–2022): 10 510(k) clearances
- Names in FDA's records: Tuttnauer Co. , Ltd. (6); Tuttnauer , Ltd. (4)
- Product codes: FLE (10)
- 510(k) review time since 2016: median 127 days, against 133 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 17 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tuttnauer U.S.A Co, Ltd.: 6 (https://510kreport.com/company/tuttnauer-usa)

## Firms that cite its devices most
- Tuttnauer U.S.A Co, Ltd.: 9 (https://510kreport.com/company/tuttnauer-usa)
- Mediline Italia S.R.L.: 1 (https://510kreport.com/company/mediline-italia)
- Barnstead/Thermolyne Corp.: 1 (https://510kreport.com/company/barnstead-thermolyne)
- Astell Scientific Limited: 1 (https://510kreport.com/company/astell-scientific)
- Fort Defiance Industries, LLC: 1 (https://510kreport.com/company/fort-defiance-industries)

## Its most-cited devices
- K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves (2011), cited by 4
- K003470: Ehs Series Table Top Autoclave, Models 2540 and 3870 (2001), cited by 3
- K063711: Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L Usa SP-2A, 69180 SP-2HA (2007), cited by 3
- K833837: American Gold Series Autoclave (1984), cited by 2
- K920478: Tuttnauer Lsi (Automatic) (1993), cited by 2
- K213080: T-Edge 10, T-Edge 11 (2022), cited by 1

## Recent decisions
- K222608: Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS (Dec 16, 2022)
- K221227: Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 (Sep 20, 2022)
- K213080: T-Edge 10, T-Edge 11 (Jan 4, 2022)
- K181456: Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves (Jul 8, 2019)
- K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves (Dec 8, 2011)
- K063711: Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L Usa SP-2A, 69180 SP-2HA (Feb 2, 2007)
- K003470: Ehs Series Table Top Autoclave, Models 2540 and 3870 (Feb 20, 2001)
- K920478: Tuttnauer Lsi (Automatic) (Jul 8, 1993)

Source page: https://510kreport.com/company/tuttnauer