FDA product code FDT: Duodenoscope And Accessories, Flexible/Rigid

FDT is the FDA product code for duodenoscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 35 510(k) submissions under FDT, 7 in the last five years, from 16 different applicants. The average 510(k) review took 147 days (median 88); 151 days on average over the last three years. FDA has posted 38 recalls for FDT devices, 18 initiated in the last five years.

Definition

To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Classification

Field	Value
Device name	Duodenoscope And Accessories, Flexible/Rigid
Device class	Class II
Regulation	21 CFR 876.1500
Review panel	GU — Gastroenterology and Urology
Medical specialty	Gastroenterology, Urology
Premarket route	510(k)

510(k) clearances per year for FDT

Year	Clearances	Avg. review days
2017	2	492
2018	3	247
2019	5	106
2020	4	64
2021	2	128
2022	1	71
2024	2	180
2025	2	92
2026	2	180

Compare with all 510(k) review times · Search every FDT clearance

Top FDT applicants

Applicant	Clearances	Latest
Olympus Medical Systems Corp.	7	2026-02-22
Fujifilm Corporation	5	2026-03-09
Pentax of America, Inc.	5	2024-08-01
Pentax Medical	3	2019-10-21
Pentax Precision Instrument Corp.	3	1996-10-10

11 more applicants have FDT clearances. See the full list in Caduvo.

Most recent FDT clearances

510(k)	Applicant	Device	Decision date	Review days
K251861	Fujifilm Corporation	FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000	2026-03-09	265
K253646	Olympus Medical Systems Corp.	Single Use Distal Cover MAJ-2315 (MAJ-2315)	2026-02-22	94
K251867	Olympus Medical Systems Corp.	EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)	2025-09-19	94
K250701	Olympus Medical Systems Corp.	Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)	2025-06-05	90
K233942	Pentax of America, Inc.	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 )	2024-08-01	231

Recalls for FDT devices

38 product recalls in 24 recall events; 18 initiated in the last five years and 18 still open. Most recent: 2026-06-05.

Year	Recalls
2017	2
2018	1
2021	4
2022	4
2023	5
2025	1
2026	7

Frequently asked questions

What is FDA product code FDT?

FDT is the FDA product code for duodenoscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.

What device class is FDT?

Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).

How long does a 510(k) take for product code FDT?

Across 35 cleared submissions the average was 147 days from receipt to decision (median 88).

Which companies have the most FDT clearances?

Olympus Medical Systems Corp. (7); Fujifilm Corporation (5); Pentax of America, Inc. (5); Pentax Medical (3); Pentax Precision Instrument Corp. (3).

Have FDT devices been recalled?

Yes: 38 product recalls across 24 recall events; the most recent began 2026-06-05.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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