Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JAX — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
291 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990962 | FLOSENSE, MODEL 29-8010 | Sdi Diagnostics, Inc. | 2000-01-07 | 291 | 0 |
| K921178 | PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS | Medical Associated Services, Inc. | 1992-08-26 | 170 | 0 |
| K884464 | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR | Spirometrics, Inc. | 1989-01-19 | 87 | 0 |
| K853085 | PAX METER | Peace Medical, Inc. | 1985-09-03 | 42 | 0 |
| K833265 | RESPIRATORY FLOW MODULE | Thoratec Laboratories Corp. | 1983-11-28 | 68 | 0 |
| K812825 | FLO-COR I | Biotrine Corp. | 1981-10-26 | 18 | 0 |
| K791730 | RING-ORIFICE, TURBULENT FLOW PNEUMOT | Research Development Corp. | 1979-11-16 | 80 | 0 |
| K770061 | VO RESPIRATORY PNEUMOTACHOGRAPH | Research Development Corp. | 1977-01-14 | 3 | 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