Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ETL — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K791938 | ATMOS ENT PATIENT CHAIR #5 | Jedmed Instrument Co. | 1979-11-13 | 47 | 0 |
| K791937 | ATMOS ENT PATIENT CHAIR #1 | Jedmed Instrument Co. | 1979-11-13 | 47 | 0 |
| K781218 | ANEMOMETER, NASAL, EXETER | Medika Corp. | 1978-07-27 | 10 | 0 |
| K772193 | NASSAL PRESSURE/FLOW RECORDER | Adco Labs. | 1977-12-02 | 4 | 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