PENTAX Medical Video Processor (EPK-i8020c)
FDA 510(k) clearance K251127 · decided 2025-06-03
Clearance details
- K-number
- K251127
- Device name
- PENTAX Medical Video Processor (EPK-i8020c)
- Applicant
- Pentax of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-11
- Decision date
- 2025-06-03
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- PEA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Montvale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL (K231249) | Pentax of America, Inc. | 2023-07-28 |
| PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL (K190805) | Pentax of America, Inc. | 2019-12-20 |
| PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family (K191282) | Pentax of America, Inc. | 2019-11-08 |
| PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (K173679) | Pentax of America, Inc. | 2018-07-03 |
| Fuse Endoscopic System with FuseBox Processor (K160275) | Endochoice, Inc. | 2016-08-01 |
| PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618) | Pentax of America, Inc. | 2015-11-24 |
| EPX-4440HD DIGITAL VIDEO PROCESSOR (K140149) | Fujifilm Medical Systems U.S.A, Inc. | 2014-08-22 |
| PENTAX EPK-I5010 VIDEO PROCESSOR (K122470) | Pentax Medical | 2013-04-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pentax Medical Video Processor; Model Number: EPK-i8020c; recall (Z-2329-2025) | Pentax of America Inc | 2025-08-15 |