510(k) · Cleared
Recalled · Class II · 2016EG-3400, 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 Oct 4, 1996 as substantially equivalent to K850020 (Pentax Precision Instrument Corp., 1985) and 2 other predicates after a 71-day review. Its family tree reaches back 2 generations to 1982. 1 of the 6 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Oct 4, 1996
- Review
- 71 days
- Class
- Class II
- Product code
- FDS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K822846 (1982). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 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 deviceK962897 EG-3400, Video GastroscopePentax Precision Instrument Corp. · 1996
Class I recalls in this family
- K850020 Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23direct predicate · 1985
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) | K962897 | EG-3400, Video Gastroscope | Pentax Precision Instrument Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 1 |
| 1994 | 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 |
|---|---|---|---|
| * | K850020 | Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23Summary page 1…EG-3400, Video Gastroscope Classification Name: Gastroscope, Gastro- Urology (78FDS), 876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. FG-23H, Fiber Gastroscope Pentax K850020 2. EC-3800L, Video Colonoscope Pentax K951574 3. EPM-3300, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The EG-3400, V… | 1985 |
| * | K951574 | EC-3800L, Video ColonoscopeSummary page 1…: Gastroscope, Gastro- Urology (78FDS), 876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. FG-23H, Fiber Gastroscope Pentax K850020 2. EC-3800L, Video Colonoscope Pentax K951574 3. EPM-3300, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The EG-3400, Video Gastroscope, must be used with a Video Pr… | 1996 |
| * | K934918 | Epm-3300 Video ProcessorSummary page 1…1500 3. PREDICATED DEVICE(S) INFORMATION: 1. FG-23H, Fiber Gastroscope Pentax K850020 2. EC-3800L, Video Colonoscope Pentax K951574 3. EPM-3300, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The EG-3400, Video Gastroscope, must be used with a Video Processor (a software controlled device). The… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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. |
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.
- 1 other device also cites its predicate K850020.
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-3400, Video Gastroscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not limited 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 procedure(s) 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/K962897 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962897: EG-3400, 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/K962897
Report an extraction error
Are you the manufacturer?
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