Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Opticon Medical, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
812 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033830 | OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPT | Opticon Medical, Inc. | 2004-01-09 | 30 | 0 |
| K023090 | OPTION-VF URINARY CATHETER, FV14218 | Opticon Medical, Inc. | 2003-03-19 | 183 | 1 |
| K970716 | OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE | Opticon Medical, Inc. | 1997-05-16 | 78 | 0 |
| K930194 | HEMOSTASIS VALVE AND TUBING SET | Opticon Medical, Inc. | 1993-09-22 | 251 | 0 |
| K904999 | WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE | Opticon Medical, Inc. | 1993-01-26 | 812 | 0 |
| K895955 | LOPER CELIAC PLEXUS BLOCK CATHETER KIT | Opticon Medical, Inc. | 1990-02-22 | 134 | 0 |
| K895476 | OPTION EPIDURAL CATHETERS | Opticon Medical, Inc. | 1990-01-19 | 130 | 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