Pentax Medical Company: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Pentax Medical Company” (first 2004, latest 2014), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 105 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 | 4 | 297 |
| 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 | 3 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 3 | 3 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 | 1 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 1 | 1 |
Review panels
Most recent Pentax Medical Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131946 | ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS | EOQ | 2014-04-25 | 302 |
| K131902 | PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) | FDS | 2014-04-10 | 289 |
| K131028 | PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) | EOQ | 2014-04-10 | 363 |
| K131855 | PENTAX VIDEO COLONOSCOPES (EC FAMILY) | FDF | 2014-04-09 | 292 |
| K093037 | PENTEX EC-3890LI | FDF | 2009-12-28 | 90 |
| K092710 | PENTAX ED-3490TK, VIDEO DUODENOSCOPE | FDT | 2009-12-02 | 90 |
| K090197 | EG-3870UTK | ODG | 2009-05-19 | 112 |
| K090196 | EG-3670URK | ODG | 2009-05-19 | 112 |
| K081518 | ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK | EOQ | 2008-09-05 | 98 |
| K061068 | EG-3670URK | ODG | 2006-05-03 | 16 |
2 earlier clearances. See the full list in Caduvo.
Recalls
30 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2016-04-06.
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.
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.
- Pentax Precision Instrument Corp. (67 510(k)s)
- Pentax of America, Inc. (44 510(k)s)
- Pentax Medical (6 510(k)s)
- Pentax Medical, A Division of Pentax of America, Inc. (2 510(k)s)
- Pentax Medical of America, Inc. (2 510(k)s)
- Pentax Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pentax Medical Company?
FDA lists 12 510(k) clearances under the applicant name “Pentax Medical Company” (first 2004, latest 2014), across 6 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 Pentax Medical Company?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pentax Medical Company is 105 days.
Which FDA product codes appear under Pentax Medical Company?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 3); ODG (Endoscopic Ultrasound System, Gastroenterology-Urology, 3); FDF (Colonoscope And Accessories, Flexible/Rigid, 2).
Next steps
- See all 12 Pentax Medical Company clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Pentax Medical Company'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.