Pentax of America, Inc.: FDA clearances and approvals
Pentax of America, Inc. has 44 FDA 510(k) clearances (first 2012, latest 2025), across 12 product codes in 3 review panels. Median 510(k) review time: 166 days. Since 2017 its median was 163 days, against 133 days for all cleared 510(k)s in the same product codes. openFDA lists 33 product recalls by a recalling firm named Pentax of America, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 175 |
| 2013 | 2 | 49 |
| 2014 | 0 | — |
| 2015 | 2 | 282 |
| 2016 | 0 | — |
| 2017 | 2 | 242 |
| 2018 | 4 | 46 |
| 2019 | 9 | 179 |
| 2020 | 4 | 102 |
| 2021 | 7 | 87 |
| 2022 | 3 | 272 |
| 2023 | 2 | 107 |
| 2024 | 5 | 193 |
| 2025 | 3 | 168 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Pentax of America, Inc.'s cleared 510(k)s took a median 163 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 9 | 9 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 6 | 6 |
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | 6 | 6 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 5 | 5 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 5 | 5 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 4 | 4 |
| GEH | Unit, Cryosurgical, Accessories | 3 | 3 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | 2 |
| EOX | Esophagoscope (Flexible Or Rigid) | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Pentax of America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | FDS | 2025-12-16 | 237 |
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) | PEA | 2025-06-03 | 53 |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | FDF | 2025-01-03 | 168 |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | FDS | 2024-12-06 | 220 |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) | FDT | 2024-08-01 | 231 |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | GEH | 2024-07-24 | 159 |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | EOQ | 2024-01-18 | 125 |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock | EOQ | 2024-01-12 | 193 |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | ODC | 2023-12-01 | 126 |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | PEA | 2023-07-28 | 88 |
34 earlier clearances. See the full list in Caduvo.
Recalls
33 product recalls in 20 recall events; 4 initiated in the last five years. Most recent: 2025-07-16.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pentax of America, Inc. have?
Pentax of America, Inc. has 44 FDA 510(k) clearances (first 2012, latest 2025), across 12 product codes in 3 review panels.
How long does FDA take to clear Pentax of America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pentax of America, Inc.'s cleared 510(k)s is 166 days. Since 2017: 163 days, versus 133 days for all cleared 510(k)s in the same product codes.
What devices does Pentax of America, Inc. make?
Its most frequent FDA product codes are EOQ (Bronchoscope (Flexible Or Rigid), 9); ODG (Endoscopic Ultrasound System, Gastroenterology-Urology, 6); PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement, 6).
Has Pentax of America, Inc. had device recalls?
openFDA lists 33 product recalls in 20 recall events by a recalling firm whose name matches Pentax of America, Inc; the most recent began 2025-07-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 44 Pentax of America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Pentax of America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.