Pentax Precision Instrument Corp.: FDA filings under this applicant name
FDA lists 67 510(k) clearances under the applicant name “Pentax Precision Instrument Corp.” (first 1979, latest 2004), across 21 product codes in 7 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | 11 | 11 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 9 | 9 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 7 | 7 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 7 | 7 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 6 | 6 |
| ITX | Transducer, Ultrasonic, Diagnostic | 4 | 4 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 3 | 3 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 3 | 3 |
| CAL | Laryngoscope, Non-Rigid | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 2 |
Plus 11 more product codes.
Review panels
- Gastroenterology and Urology (46)
- Ear, Nose and Throat (12)
- Radiology (4)
- Anesthesiology (2)
- General Hospital (1)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Pentax Precision Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041397 | EG-3830UT | ITX | 2004-06-09 | 14 |
| K041396 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | ITX | 2004-06-09 | 14 |
| K041395 | EG-3630UR | ITX | 2004-06-09 | 14 |
| K031789 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | ODG | 2003-08-08 | 59 |
| K023401 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | ODG | 2003-02-11 | 125 |
| K023376 | EB-1830T3, VIDEO BRONCHOSCOPE | EOQ | 2002-10-16 | 8 |
| K021276 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | ODG | 2002-09-12 | 143 |
| K021278 | EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE | ODG | 2002-09-06 | 137 |
| K013640 | EG-3630UR, ULTRASUND VIDEO GASTROSCOPE | FDS | 2002-02-04 | 91 |
| K010740 | FG-36UX, FIBER ULTRASOUND GASTROSCOPE | ODG | 2001-04-17 | 35 |
57 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pentax Precision Instrument Corp..
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 of America, Inc. (44 510(k)s)
- Pentax Medical Company (12 510(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 Precision Instrument Corp.?
FDA lists 67 510(k) clearances under the applicant name “Pentax Precision Instrument Corp.” (first 1979, latest 2004), across 21 product codes in 7 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 Precision Instrument Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pentax Precision Instrument Corp. is 71 days.
Which FDA product codes appear under Pentax Precision Instrument Corp.?
The most frequent FDA product codes under this applicant name are FDF (Colonoscope And Accessories, Flexible/Rigid, 11); EOQ (Bronchoscope (Flexible Or Rigid), 9); FDS (Gastroscope And Accessories, Flexible/Rigid, 7).
Next steps
- See all 67 Pentax Precision Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code FDF, Pentax Precision Instrument Corp.'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.