Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Codonics, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
259 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101439 | CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P | Codonics, Inc. | 2011-02-07 | 259 | 0 |
| K060440 | CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONIC | Codonics, Inc. | 2006-03-16 | 23 | 0 |
| K042232 | NP-2600 SERIES HARDCOPY PRINTERS | Codonics, Inc. | 2004-10-05 | 49 | 0 |
| K030690 | CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS | Codonics, Inc. | 2003-04-30 | 56 | 0 |
| K021054 | CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS | Codonics, Inc. | 2002-05-09 | 38 | 0 |
| K003481 | CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 | Codonics, Inc. | 2001-01-19 | 71 | 0 |
| K962364 | CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) | Codonics, Inc. | 1996-11-08 | 142 | 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