Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diamond Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
204 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924758 | DMI BLOOD GAS ANALYZER/CARTRIDGE | Diamond Medical, Inc. | 1992-12-03 | 71 | 1 |
| K915087 | DMI BLOD GAS ANALYZER/CARTRIDGE | Diamond Medical, Inc. | 1992-01-08 | 57 | 0 |
| K874709 | DIAMOND MEDICAL, INC. MODEL DM 800 | Diamond Medical, Inc. | 1988-02-08 | 88 | 0 |
| K874710 | DIAMOND MEDICAL, INC. MODEL DM 600 | Diamond Medical, Inc. | 1988-02-08 | 88 | 0 |
| K875369 | MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT | Diamond Medical, Inc. | 1988-02-05 | 36 | 0 |
| K863298 | DIAMOND MEDICAL, INC., MODEL DM 700 | Diamond Medical, Inc. | 1987-03-17 | 204 | 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