Opticon Medical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Opticon Medical, Inc.” (first 1990, latest 2004), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 132 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 4 | 4 |
| CAZ | Anesthesia Conduction Kit | 2 | 2 |
| BSR | Stylet, Tracheal Tube | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
Review panels
Most recent Opticon Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041983 | OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 | EZL | 2004-11-17 | 117 |
| K033830 | OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 | EZL | 2004-01-09 | 30 |
| K023090 | OPTION-VF URINARY CATHETER, FV14218 | EZL | 2003-03-19 | 183 |
| K970716 | OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE | EZL | 1997-05-16 | 78 |
| K930194 | HEMOSTASIS VALVE AND TUBING SET | DYB | 1993-09-22 | 251 |
| K904999 | WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE | BSR | 1993-01-26 | 812 |
| K895955 | LOPER CELIAC PLEXUS BLOCK CATHETER KIT | CAZ | 1990-02-22 | 134 |
| K895476 | OPTION EPIDURAL CATHETERS | CAZ | 1990-01-19 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Opticon Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Opticon Medical, Inc. (7)
- Opticon Medical (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Opticon Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Opticon Medical, Inc.?
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Opticon Medical, Inc.” (first 1990, latest 2004), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Opticon Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Opticon Medical, Inc. is 132 days.
Which FDA product codes appear under Opticon Medical, Inc.?
The most frequent FDA product codes under this applicant name are EZL (Catheter, Retention Type, Balloon, 4); CAZ (Anesthesia Conduction Kit, 2); BSR (Stylet, Tracheal Tube, 1).
Next steps
- See all 8 Opticon Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EZL, Opticon Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.