Tuttnauer U.S.A Co, Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Tuttnauer U.S.A Co, Ltd.” (first 1997, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 123 days. 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 | 1 | 58 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 88 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tuttnauer U.S.A Co, Ltd. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLE | Sterilizer, Steam | 8 | 8 |
| FRG | Wrap, Sterilization | 1 | 1 |
Review panels
- General Hospital (9)
Most recent Tuttnauer U.S.A Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232658 | T-Top 10 & T-Top T-Top 11 | FLE | 2023-11-27 | 88 |
| K143311 | Pre-vacuum Tabletop Autoclave | FLE | 2015-01-15 | 58 |
| K090783 | TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE | FLE | 2009-08-20 | 150 |
| K032192 | PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V | FLE | 2004-08-12 | 392 |
| K021504 | TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 | FLE | 2002-07-25 | 77 |
| K993856 | TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP | FLE | 2001-02-09 | 452 |
| K990761 | TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE | FRG | 1999-07-09 | 123 |
| K962282 | TUTTNAUER PREVACUUM TABLE AUTOCLAVE | FLE | 1997-11-12 | 518 |
| K973550 | TUTTNAUER TABLE-TOP AUTOCLAVE | FLE | 1997-10-29 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Tuttnauer U.S.A 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 Co. , Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tuttnauer U.S.A Co, Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Tuttnauer U.S.A Co, Ltd.” (first 1997, latest 2023), across 2 product codes 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 U.S.A Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tuttnauer U.S.A Co, Ltd. is 123 days.
Which FDA product codes appear under Tuttnauer U.S.A Co, Ltd.?
The most frequent FDA product codes under this applicant name are FLE (Sterilizer, Steam, 8); FRG (Wrap, Sterilization, 1).
Next steps
- See all 9 Tuttnauer U.S.A Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FLE, Tuttnauer U.S.A 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.