Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cox-Uphuff Intl. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
88 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874276 | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER | Cox-Uphuff Intl. | 1987-12-02 | 43 | 0 |
| K874342 | LIGATURE CARRIER/PACKER, HYDROXYLAPATITE | Cox-Uphuff Intl. | 1987-11-13 | 24 | 0 |
| K873470 | TEMPLATE | Cox-Uphuff Intl. | 1987-09-08 | 11 | 0 |
| K865056 | CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER | Cox-Uphuff Intl. | 1987-05-22 | 149 | 1 |
| K871200 | CUI NASAL SEPTUM BUTTON | Cox-Uphuff Intl. | 1987-04-15 | 21 | 0 |
| K865033 | BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER | Cox-Uphuff Intl. | 1987-01-12 | 20 | 0 |
| K854339 | CUI CHIN SIZER | Cox-Uphuff Intl. | 1985-11-15 | 18 | 0 |
| K853945 | CUI RHINOPLASTY IMPLANTS | Cox-Uphuff Intl. | 1985-10-18 | 24 | 0 |
| K831566 | CUI MAMMARY PROTHESIS SIZER | Cox-Uphuff Intl. | 1983-08-12 | 88 | 1 |
| K813394 | DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM | Cox-Uphuff Intl. | 1982-01-22 | 49 | 0 |
| K802214 | COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM | Cox-Uphuff Intl. | 1980-10-23 | 41 | 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