PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
FDA 510(k) K191282 · Pentax of America, Inc.
510(k) numberK191282
Submission
- Device name
- PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
- Applicant
- Pentax of America, Inc.
Montvale, NJ, US - Received
- May 13, 2019
- Decision date
- November 8, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEA – Endoscope, Accessories, Image Post-Processing For Color Enhancement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
Other 510(k)s with product code PEA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251127 | PENTAX Medical Video Processor (EPK-i8020c)PEA · Traditional | Pentax of America, Inc. | 06/03/2025SE |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…PEA · Traditional | Pentax of America, Inc. | 07/28/2023SE |
| K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…PEA · Traditional | Pentax of America, Inc. | 12/20/2019SE |
| K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPEA · Traditional | Pentax of America, Inc. | 07/03/2018SE |
| K160275 | Fuse Endoscopic System with FuseBox ProcessorPEA · Traditional | Endochoice, Inc. | 08/01/2016SE |
| K150618 | PENTAX Medical EPK-i7010 Video Processor with GI FamilyPEA · Traditional | Pentax of America, Inc. | 11/24/2015SE |
| K140149 | EPX-4440HD Digital Video ProcessorPEA · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 08/22/2014SE |
| K122470 | Pentax EPK-I5010 Video ProcessorPEA · Traditional | Pentax Medical | 04/10/2013SE |
More from Pentax Medical
| 510(k) | Device | Decision |
|---|---|---|
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…FDS · Traditional | 12/16/2025SE |
| K251127 | PENTAX Medical Video Processor (EPK-i8020c)PEA · Traditional | 06/03/2025SE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | 01/03/2025SE |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope…FDS · Traditional | 12/06/2024SE |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…FDT · Traditional | 08/01/2024SE |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)GEH · Traditional | 07/24/2024SE |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…EOQ · Traditional | 01/18/2024SE |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…EOQ · Traditional | 01/12/2024SE |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14ODC · Traditional | 12/01/2023SE |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…PEA · Traditional | 07/28/2023SE |
Questions and answers
When was PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family cleared by the FDA?
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family (K191282) received a 510(k) decision of Substantially Equivalent on November 8, 2019, 179 days after the submission was received.
What is the product code of K191282?
The FDA product code is PEA – Endoscope, Accessories, Image Post-Processing For Color Enhancement, a Class II (moderate risk) device regulated under 21 CFR 876.1500.