Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sontek Industries, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
41 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833361 | TUBE-TITLE | Sontek Industries, Inc. | 1983-11-03 | 37 | 0 |
| K833374 | BITE-BLOCK | Sontek Industries, Inc. | 1983-11-03 | 37 | 0 |
| K833372 | BODIA TRACH-SAF DOUBLE SWIVEL | Sontek Industries, Inc. | 1983-11-03 | 37 | 0 |
| K833373 | BODIA BRONCH-SAF DOUBLE SWIVEL | Sontek Industries, Inc. | 1983-11-03 | 37 | 0 |
| K813324 | BODAI SWIVEL Y | Sontek Industries, Inc. | 1981-12-29 | 35 | 0 |
| K812720 | BODAI PATIENT COMMUNICATOR | Sontek Industries, Inc. | 1981-11-05 | 41 | 0 |
| K811241 | BODAI SUCTION -SAFE 4 | Sontek Industries, Inc. | 1981-05-27 | 23 | 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