Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diametrics Medical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
177 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030035 | IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE | Diametrics Medical, Inc. | 2003-06-25 | 173 | 0 |
| K013938 | IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE | Diametrics Medical, Inc. | 2002-01-28 | 61 | 0 |
| K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | Diametrics Medical, Inc. | 2001-11-16 | 177 | 0 |
| K981270 | IRMA BLOOD ANALYSIS SYSTEM | Diametrics Medical, Inc. | 1998-05-01 | 24 | 0 |
| K980523 | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE | Diametrics Medical, Inc. | 1998-03-19 | 37 | 0 |
| K974396 | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP P | Diametrics Medical, Inc. | 1997-12-18 | 27 | 0 |
| K945240 | IRMA BLOOD ANALYSIS SYSTEM | Diametrics Medical, Inc. | 1995-01-05 | 70 | 4 |
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