Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Timeter Group — 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) |
|---|---|---|---|---|---|
| K871452 | CLASSIC (TM) 200 OXYGEN FLOWMETER | The Timeter Group | 1987-06-22 | 70 | 0 |
| K862171 | MP-500 ELECTRONIC NEBULIZER | The Timeter Group | 1986-07-14 | 35 | 0 |
| K852374 | OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18 | The Timeter Group | 1985-07-12 | 38 | 0 |
| K844556 | KHM 2000 DRIP WATCHER | The Timeter Group | 1985-01-14 | 54 | 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