Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carefusion 209, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
241 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120979 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | 2012-04-25 | 23 | 0 |
| K112052 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | 2012-03-15 | 241 | 0 |
| K112034 | TECA ELITE DISPOSABLE CONCENTRIC NEEDLES | Carefusion 209, Inc. | 2011-08-12 | 28 | 0 |
| K111131 | TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES | Carefusion 209, Inc. | 2011-06-17 | 57 | 0 |
| K103140 | NICOLET WIRELESS EEG | Carefusion 209, Inc. | 2011-04-08 | 165 | 1 |
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