Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tonometrics, Inc. — 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) |
|---|---|---|---|---|---|
| K920849 | TRIP CIC CATHETER | Tonometrics, Inc. | 1995-03-17 | 1116 | 0 |
| K911825 | TRIP(TM) NASOGASTRIC SUMP CATHETER | Tonometrics, Inc. | 1991-07-23 | 90 | 0 |
| K890466 | SIGMOID TONOMITOR | Tonometrics, Inc. | 1989-04-21 | 80 | 0 |
| K883234 | TONOMITOR (TM) + SUMP | Tonometrics, Inc. | 1988-10-12 | 72 | 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