Pentax Medical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Pentax Medical” (first 2013, latest 2019), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 266 days. Since 2017 the median was 272 days, against 175 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 1 | 240 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 272 |
| 2018 | 3 | 470 |
| 2019 | 1 | 60 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pentax Medical took a median 272 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 3 | 3 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 2 |
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | 1 | 1 |
Review panels
Most recent Pentax Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | FDT | 2019-10-21 | 60 |
| K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | EOB | 2018-07-18 | 470 |
| K172156 | PENTAX Medical EPK-3000 Video Imaging System | EOB | 2018-04-05 | 261 |
| K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | FDT | 2018-02-07 | 649 |
| K163614 | PENTAX Medical ED34-i10T, Video Duodenoscope | FDT | 2017-09-20 | 272 |
| K122470 | PENTAX EPK-I5010 VIDEO PROCESSOR | PEA | 2013-04-10 | 240 |
Recalls
openFDA lists no recalls under a recalling firm named Pentax Medical.
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.
Device clinical trials
An industry sponsor named Pentax Medical is the lead sponsor of 11 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT06483503: Extra Wide Field of View Lens Study (Active not recruiting, started 2024-08-21)
- NCT03311451: C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study. (Enrolling by invitation, started 2023-01-16)
- NCT05349240: C2 Esophageal Squamous Epithelium Dysplasia (Recruiting, started 2022-11-18)
- NCT03097666: Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus (Completed, started 2017-03-20)
- NCT02729753: Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium (Completed, started 2016-04)
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 Company (12 510(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?
FDA lists 6 510(k) clearances under the applicant name “Pentax Medical” (first 2013, latest 2019), across 3 product codes in 2 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pentax Medical is 266 days. Since 2017: 272 days, versus 175 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pentax Medical?
The most frequent FDA product codes under this applicant name are FDT (Duodenoscope And Accessories, Flexible/Rigid, 3); EOB (Nasopharyngoscope (Flexible Or Rigid), 2); PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement, 1).
Next steps
- See all 6 Pentax Medical clearances with predicates and recalls
- Run predicate analysis for product code FDT, Pentax Medical'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.