Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

46 results for "Pentax of America, Inc."
1–24 of 46
Search insights Median review: 159d Cleared: 100% Top manufacturer: Pentax of America, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 16, 2025
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
K251256 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 237d
Cleared Jun 03, 2025
PENTAX Medical Video Processor (EPK-i8020c)
K251127 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 53d
Cleared Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
K242110 · FDF
Pentax of America, Inc.
Gastroenterology & Urology · 168d
Cleared Dec 06, 2024
PENTAX Medical Video Upper GI Scope (EG27-i20c)
K241213 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 220d
Cleared Aug 01, 2024
PENTAX Medical Video Duodenoscope (ED34-i10T2s)
K233942 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 231d
Cleared Jul 24, 2024
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
K240457 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 159d
Cleared Jan 18, 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope...
K232860 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 125d
Cleared Jan 12, 2024
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single...
K231970 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 193d
Cleared Dec 01, 2023
PENTAX Medical Gas/Water Feeding Valve OE-B14
K232249 · ODC
Pentax of America, Inc.
Gastroenterology & Urology · 126d
Cleared Jul 28, 2023
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI...
K231249 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 21, 2022
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
K213235 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 447d
Cleared Dec 02, 2022
PENTAX Medical Video Esophagoscope EE17-J10
K223072 · EOX
Pentax of America, Inc.
Ear, Nose, Throat · 63d
Cleared Nov 16, 2022
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX...
K220465 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 272d
Cleared Nov 29, 2021
C2 CryoBalloon Ablation System
K212814 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 87d
Cleared Oct 21, 2021
PENTAX Medical Video Bronchoscope EB11-J10
K210928 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 206d
Cleared Oct 20, 2021
PENTAX Medical Video Upper GI Scopes EG17-J10
K210177 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 271d
Cleared Oct 01, 2021
PENTAX Medical Auto Leakage Tester SHA-P6
K212201 · PCV
Pentax of America, Inc.
Gastroenterology & Urology · 79d
Cleared May 13, 2021
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video...
K210485 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 09, 2021
PENTAX Medical Video Duedenoscope ED34-i10T2
K210710 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 01, 2021
Pentax Medical Video Duodenoscope ED32-i10
K202365 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 225d
Cleared Dec 30, 2020
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical...
K203166 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 68d
Cleared Nov 24, 2020
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2...
K203024 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 53d
Cleared Jul 30, 2020
PENTAX Medical Video Bronchoscope EB-J10 Series
K200678 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 136d
Cleared Jul 23, 2020
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound...
K200090 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 189d