Codonics, Inc.: FDA clearances and approvals
Codonics, Inc. has 7 FDA 510(k) clearances (first 1996, latest 2011), across 2 product codes in 2 review panels. Median 510(k) review time: 56 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | 6 | 6 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
Review panels
- Radiology (6)
- Anesthesiology (1)
Most recent Codonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101439 | CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P | BSZ | 2011-02-07 | 259 |
| K060440 | CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER | LMC | 2006-03-16 | 23 |
| K042232 | NP-2600 SERIES HARDCOPY PRINTERS | LMC | 2004-10-05 | 49 |
| K030690 | CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS | LMC | 2003-04-30 | 56 |
| K021054 | CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER | LMC | 2002-05-09 | 38 |
| K003481 | CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 | LMC | 2001-01-19 | 71 |
| K962364 | CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) | LMC | 1996-11-08 | 142 |
Recalls
openFDA lists no recalls under a recalling firm named Codonics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Codonics, Inc. have?
Codonics, Inc. has 7 FDA 510(k) clearances (first 1996, latest 2011), across 2 product codes in 2 review panels.
How long does FDA take to clear Codonics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Codonics, Inc.'s cleared 510(k)s is 56 days.
What devices does Codonics, Inc. make?
Its most frequent FDA product codes are LMC (Camera, Multi Format, Radiological, 6); BSZ (Gas-Machine, Anesthesia, 1).
Has Codonics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Codonics, Inc. Related entities may recall under other names.
Next steps
- See all 7 Codonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LMC, Codonics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.