510(k) · Cleared

Recalled · Class I · 2016

Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23

K850020510(k) TraditionalCleared Jul 9, 1985186-day reviewClass II21 CFR 876.1500Recalls 3 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pentax Precision Instrument Corp. · FDS Gastroscope And Accessories, Flexible/Rigid

Cleared on Jul 9, 1985 after a 186-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 13 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it. It has been recalled 3 times, including a Class I recall.

Decided: Jul 9, 1985
Review: 186 days
Class: Class II
Product code: FDS
Recalls: 3 (1 Class I)
Predicates: 0

12 later devices descend from it, 2 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.

This deviceK850020 Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23Pentax Precision Instrument Corp. · 1985
Descendant · cites it directly · 10 of its ownK961564 EG-2940, Video GastroscopePentax Precision Instrument Corp. · 1996 · Recalled
Descendant · 2 generations on · 9 of its ownK013640 EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp. · 2002
Descendant · 3 generations on · 8 of its ownK063847 Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR…Fujinon, Inc. · 2007 · Recalled
Descendant · 4 generations on · 7 of its ownK111243 Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
Descendant · 4 generations on · 4 of its ownK120446 Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1996high 2 (1996) · low 0 (1997)2026

Most influential descendants

Showing 5 of 12 · See all

K961564EG-2940, Video GastroscopePentax Precision Instrument Corp. · 1996 · cites it directly10descendants
K013640EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp. · 2002 · 2 generations on9descendants
K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc. · 2007 · 3 generations on8descendants
K111243Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011 · 4 generations on7descendants
K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K850020	Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23	Pentax Precision Instrument Corp.	1985	—
+1	K961564	EG-2940, Video Gastroscope	Pentax Precision Instrument Corp.	1996	2
+2	K013640	EG-3630UR, Ultrasund Video Gastroscope	Pentax Precision Instrument Corp.	2002	—
+3	K063847	Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700	Fujinon, Inc.	2007	1
+4	K111243	Fujinon Ultrasonic Processor	Fujinon, Inc.	2011	—
+4	K120446	Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2	Fujinon, Inc.	2012	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
2002	1	0
2007	1	0
2011	1	0
2012	1	0
2016	1	0
2018	1	0
2019	1	0
2020	1	0
2022	2	0

FIG. 1 — Lineage of K850020, 1985–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FDS device

#1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K961564	EG-2940, Video Gastroscope	Pentax Precision Instrument Corp.	1996	10
K962897	EG-3400, Video Gastroscope	Pentax Precision Instrument Corp.	1996	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 6, 2016	Class II	Z-2071-2016	Device Design	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.
Jul 17, 2014	Class II	Z-2290-2014	Labeling design	The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
Sep 16, 2013	Class I	Z-0084-2014	Use error	PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K961564 (Pentax Precision Instrument Corp., 1996) has gone furthest, with 10 descendants of its own.

How does its category compare?

All FDS devices

FDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FDS

8in 2025

2007high 8 (2025) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDS

211in 2025

2007high 220 (2024) · low 78 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FDS

2in 2024

2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FDS

18,905in 2025

2007high 18,905 (2025) · low 8 (2013)2025

MAUDE reports naming product code FDS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	27
2008	0	—	0	11
2009	0	—	0	21
2010	1	—	0	45
2011	1	—	0	36
2012	3	181	0	35
2013	2	—	1	8
2014	2	—	0	23
2015	2	—	0	29
2016	1	—	1	108
2017	1	—	0	178
2018	6	167	0	304
2019	5	175	0	1,376
2020	2	—	2	601
2021	5	78	0	1,755
2022	2	—	0	6,216
2023	3	133	0	9,874
2024	5	220	2	9,258
2025	8	211	0	18,905
2026	7	164	0	—

https://510kreport.com/device/K850020 · printed Nov 6, 2026

Cite this page

510(k) Report. “K850020: Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850020

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026