Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tuttnauer , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 387 | Tuttnauer , Ltd. | 2022-12-16 | 109 | 0 |
| K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 669 | Tuttnauer , Ltd. | 2022-09-20 | 145 | 0 |
| K213080 | T-Edge 10, T-Edge 11 | Tuttnauer , Ltd. | 2022-01-04 | 103 | 0 |
| K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 6 | Tuttnauer , Ltd. | 2019-07-08 | 399 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda