Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ttbio Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
285 daysmedian FDA review time
320 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232243 | EVO 700 series high speed handpiece | Ttbio Corp. | 2023-08-23 | 26 | 0 |
| K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. | 2022-02-02 | 320 | 0 |
| K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | Ttbio Corp. | 2020-12-04 | 200 | 0 |
| K190508 | EVO 450 series High Speed Handpieces | Ttbio Corp. | 2019-12-11 | 285 | 0 |
| K141183 | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIE | Ttbio Corp. | 2015-02-27 | 296 | 0 |
| K132570 | ELECTRIC HANDPIECE SYSTEM | Ttbio Corp. | 2014-04-29 | 257 | 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