510(k) · Cleared
Recalled · Class II · 2016EG-2940, Video Gastroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Precision Instrument Corp. · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Jul 9, 1996 as substantially equivalent to K951574 (Pentax Precision Instrument Corp., 1996) and 2 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1982. 1 of the 16 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 9, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- FDS
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K822846 (1982). 5 ancestors in all. 10 later devices descend from it, 1 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK822846 Pentax FC-38LA & FC-38SA ColonofiberPentax Precision Instrument Corp. · 1982
- 1 generation backK951574 EC-3800L, Video ColonoscopePentax Precision Instrument Corp. · 1996 · Recalled
- This deviceK961564 EG-2940, Video GastroscopePentax Precision Instrument Corp. · 1996
- Descendant · cites it directly · 9 of its ownK013640 EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp. · 2002
- Descendant · 2 generations on · 8 of its ownK063847 Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR…Fujinon, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 7 of its ownK111243 Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK120446 Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 3 of its ownK181763 FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K850020 Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23direct predicate · 1985
Most influential descendants
Showing 5 of 10 · See all- K013640EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp. · 2002 · cites it directly9descendants
- K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc. · 2007 · 2 generations on8descendants
- K111243Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011 · 3 generations on7descendants
- K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012 · 3 generations on4descendants
- K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K822846 | Pentax FC-38LA & FC-38SA Colonofiber | Pentax Precision Instrument Corp. | 1982 | — |
| −1 | K951574 | EC-3800L, Video Colonoscope | Pentax Precision Instrument Corp. | 1996 | 3 |
| 0 (this device) | K961564 | EG-2940, Video Gastroscope | Pentax Precision Instrument Corp. | 1996 | — |
| +1 | K013640 | EG-3630UR, Ultrasund Video Gastroscope | Pentax Precision Instrument Corp. | 2002 | — |
| +2 | K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 | Fujinon, Inc. | 2007 | 1 |
| +3 | K111243 | Fujinon Ultrasonic Processor | Fujinon, Inc. | 2011 | — |
| +3 | K120446 | Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2 | Fujinon, Inc. | 2012 | 1 |
| +4 | K181763 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 1 |
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951574 | EC-3800L, Video ColonoscopeSummary page 1…G-2940, Video Gastroscope Classification Name: Gastroscope, Gastro- Urology ,(FDS), 876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. EC-3800L, Video Colonoscope Pentax K951574 2. FG-23H, Fiber Gastroscope Pentax K850020 3. EPM-330, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The EG-2940, Vide… | 1996 |
| * | K850020 | Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23Summary page 1…e: Gastroscope, Gastro- Urology ,(FDS), 876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. EC-3800L, Video Colonoscope Pentax K951574 2. FG-23H, Fiber Gastroscope Pentax K850020 3. EPM-330, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The EG-2940, Video Gastroscope, must be used with a Video Pro… | 1985 |
| * | K934918 | Epm-3300 Video ProcessorSummary page 1….1500 3. PREDICATED DEVICE(S) INFORMATION: 1. EC-3800L, Video Colonoscope Pentax K951574 2. FG-23H, Fiber Gastroscope Pentax K850020 3. EPM-330, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The EG-2940, Video Gastroscope, must be used with a Video Processor (a software controlled device). The… | 1994 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013640 | EG-3630UR, Ultrasund Video Gastroscope | 2002 | 9 |
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. |
| Sep 30, 2011 | Not classified | Z-0819-2012 | Employee error | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K850020Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23Pentax Precision Instrument Corp. · 1985 · Direct predicate · ◆ in the 1985 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 13.4 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K013640 (Pentax Precision Instrument Corp., 2002) has gone furthest, with 9 descendants of its own.
- 7 other devices also cite its predicate K951574.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 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 | — |
What is it indicated for?
The EG-2940, Video Gastroscope, is intended to provide visualization (via a video monitor) of], and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Small Bowel. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961564 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961564: EG-2940, Video Gastroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961564
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026