Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Faulding Medical Device Co. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
409 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962159 | STERILE AMBULATORY RESERVOIR 60ML/100ML | Faulding Medical Device Co. | 1997-07-18 | 409 | 0 |
| K970909 | SAFE-CONNECT I.V. SET | Faulding Medical Device Co. | 1997-05-06 | 55 | 0 |
| K970789 | SAFE-CONNECT VIAL DISPENSING SPIKE | Faulding Medical Device Co. | 1997-05-01 | 58 | 0 |
| K971266 | SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518 | Faulding Medical Device Co. | 1997-05-01 | 27 | 0 |
| K970524 | SAFE-CONNECT I.V. EXTENSION SET | Faulding Medical Device Co. | 1997-04-22 | 70 | 0 |
| K955775 | SAFECONNECT VALVE (CATALOG NO. XXXX) | Faulding Medical Device Co. | 1996-11-15 | 330 | 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