Pentax Video Colonoscopes (Ec Family)

510(k) K131855

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK131855	Date9 Apr 2014Cleared	StatusActive

6 recalls · 2 ongoing · FDA

2 recalls, same reason
- Ongoing Z-2449-2021 FDA Class II initiated 14 Jul 2021
- Ongoing Z-2448-2021 FDA Class II initiated 14 Jul 2021
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
2 recalls, same reason
- Terminated Z-1267-2020 FDA Class II initiated 3 Jan 2020
- Terminated Z-1268-2020 FDA Class II initiated 3 Jan 2020
Distributed in the USA without an approved 510K
- Terminated Z-0636-2017 FDA Class II initiated 15 Aug 2016
Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).
- Terminated Z-2068-2016 FDA Class II initiated 6 Apr 2016
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

1 jurisdiction

United States — FDA 510(k) Active

510(k)