Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Critical Device Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
240 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983926 | MPS GRAVITY FLOW CONTROL SET | Critical Device Corp. | 1999-01-20 | 76 | 0 |
| K964918 | NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW P | Critical Device Corp. | 1997-04-14 | 126 | 8 |
| K964989 | CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) | Critical Device Corp. | 1997-04-02 | 110 | 0 |
| K964812 | NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET | Critical Device Corp. | 1997-02-10 | 73 | 0 |
| K952852 | NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET | Critical Device Corp. | 1996-02-16 | 240 | 0 |
| K955896 | MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 | Critical Device Corp. | 1996-02-06 | 39 | 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