Tuttnauer Co. , Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Tuttnauer Co. , Ltd.” (first 1984, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 120 days. Since 2017 the median was 127 days, against 139 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 399 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 3 | 109 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tuttnauer Co. , Ltd. took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 139 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLE | Sterilizer, Steam | 10 | 10 |
Review panels
- General Hospital (10)
Most recent Tuttnauer Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | FLE | 2022-12-16 | 109 |
| K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | FLE | 2022-09-20 | 145 |
| K213080 | T-Edge 10, T-Edge 11 | FLE | 2022-01-04 | 103 |
| K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | FLE | 2019-07-08 | 399 |
| K111736 | TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES | FLE | 2011-12-08 | 171 |
| 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 | 2007-02-02 | 50 |
| K003470 | EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 | FLE | 2001-02-20 | 104 |
| K920478 | TUTTNAUER LSI (AUTOMATIC) | FLE | 1993-07-08 | 526 |
| K850264 | TUTTNAUER PRE-VACUUM AUTOCLAVE | FLE | 1985-06-04 | 132 |
| K833837 | AMERICAN GOLD SERIES AUTOCLAVE | FLE | 1984-01-11 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named Tuttnauer Co. , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tuttnauer U.S.A Co, Ltd. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tuttnauer Co. , Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Tuttnauer Co. , Ltd.” (first 1984, latest 2022), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tuttnauer Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tuttnauer Co. , Ltd. is 120 days. Since 2017: 127 days, versus 139 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tuttnauer Co. , Ltd.?
The most frequent FDA product codes under this applicant name are FLE (Sterilizer, Steam, 10).
Next steps
- See all 10 Tuttnauer Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FLE, Tuttnauer Co. , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.