Cp Medical: FDA clearances and approvals
Cp Medical has 32 FDA 510(k) clearances (first 1982, latest 2018), across 20 product codes in 7 review panels. Median 510(k) review time: 73 days. openFDA lists 3 product recalls by a recalling firm named Cp Medical.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 90 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cp Medical's cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 161 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 6 | 6 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 3 | 3 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 3 | 3 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 2 | 2 |
| MTJ | Wax, Bone | 2 | 2 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 2 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| EIB | Syringe, Irrigating (Dental) | 1 | 1 |
| FIB | Protector, Transducer, Dialysis | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Plus 10 more product codes.
Review panels
- General and Plastic Surgery (17)
- Radiology (6)
- Gastroenterology and Urology (4)
- Orthopedic (2)
- Cardiovascular (1)
- Dental (1)
- General Hospital (1)
Most recent Cp Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173922 | C-PTFETM Surgical Suture | NBY | 2018-03-26 | 90 |
| K094028 | CP-FIBER (ORTHOFIBER) | GAT | 2010-03-18 | 78 |
| K072229 | MONOSWIFT | GAM | 2007-10-05 | 56 |
| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | KXK | 2007-07-18 | 42 |
| K060987 | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 | MTJ | 2006-11-02 | 206 |
| K041894 | ORTHOFIBER | GAT | 2004-09-17 | 66 |
| K034062 | CP SLEEVE AND RIVER SLEEVE | KXK | 2004-01-30 | 30 |
| K024372 | CP MEDICAL BONE WAX | MTJ | 2003-06-19 | 170 |
| K030786 | MONO-SWIFT | NEW | 2003-05-06 | 55 |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | GAQ | 2003-03-28 | 53 |
22 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2019-10-18.
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 Cp Medical have?
Cp Medical has 32 FDA 510(k) clearances (first 1982, latest 2018), across 20 product codes in 7 review panels.
How long does FDA take to clear Cp Medical's 510(k)s?
The median time from FDA receipt to decision across Cp Medical's cleared 510(k)s is 73 days.
What devices does Cp Medical make?
Its most frequent FDA product codes are KXK (Source, Brachytherapy, Radionuclide, 6); GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 3); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 3).
Has Cp Medical had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Cp Medical; the most recent began 2019-10-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 32 Cp Medical clearances with predicates and recalls
- Run predicate analysis for product code KXK, Cp Medical'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.