Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tuttnauer U.S.A Co, Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
518 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023-11-27 | 88 | 0 |
| K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015-01-15 | 58 | 0 |
| K090783 | TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE | Tuttnauer U.S.A Co, Ltd. | 2009-08-20 | 150 | 0 |
| K032192 | PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDI | Tuttnauer U.S.A Co, Ltd. | 2004-08-12 | 392 | 0 |
| K021504 | TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 | Tuttnauer U.S.A Co, Ltd. | 2002-07-25 | 77 | 0 |
| K993856 | TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP | Tuttnauer U.S.A Co, Ltd. | 2001-02-09 | 452 | 0 |
| K990761 | TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE C | Tuttnauer U.S.A Co, Ltd. | 1999-07-09 | 123 | 0 |
| K962282 | TUTTNAUER PREVACUUM TABLE AUTOCLAVE | Tuttnauer U.S.A Co, Ltd. | 1997-11-12 | 518 | 0 |
| K973550 | TUTTNAUER TABLE-TOP AUTOCLAVE | Tuttnauer U.S.A Co, Ltd. | 1997-10-29 | 41 | 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