Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S & M Instrument Co. — 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) |
|---|---|---|---|---|---|
| K951367 | PORTA-SCREEN SPIROMETER | S & M Instrument Co. | 1995-04-14 | 18 | 0 |
| K943146 | PORTA-RESP MONITOR | S & M Instrument Co. | 1994-11-28 | 151 | 0 |
| K920877 | THE KEYSTONE SYSTEM | S & M Instrument Co. | 1992-12-23 | 301 | 0 |
| K884051 | DSM-1 DOSIMETER | S & M Instrument Co. | 1988-12-16 | 81 | 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