Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Technical Medical Products, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970163 | ALPHA MX (20)/ULTRA PC (30) | Technical Medical Products, Inc. | 1997-12-10 | 328 | 0 |
| K896510 | TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR. | Technical Medical Products, Inc. | 1990-01-22 | 69 | 0 |
| K884167 | TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR. | Technical Medical Products, Inc. | 1988-10-28 | 24 | 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