510(k) · Cleared
ClearedEC-384OTL, Video Colonscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Precision Instrument Corp. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Jun 19, 1996 as substantially equivalent to K951579 (Pentax Precision Instrument Corp., 1996) and 1 other predicate after a 57-day review. Its family tree reaches back 2 generations to 1982. 39 later devices descend from it.
- Decided
- Jun 19, 1996
- Review
- 57 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K822846 (1982). 4 ancestors in all. 39 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK822846 Pentax FC-38LA & FC-38SA ColonofiberPentax Precision Instrument Corp. · 1982
- 1 generation backK951579 EC-3800TL, Video ColonoscopePentax Precision Instrument Corp. · 1996 · Recalled
- This deviceK961563 EC-384OTL, Video ColonscopePentax Precision Instrument Corp. · 1996
- Descendant · cites it directly · 38 of its ownK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- Descendant · 2 generations on · 13 of its ownK091305 ClearpathEasyglide, Ltd. · 2009
- Descendant · cites it directly · 13 of its ownK052930 Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK070622 Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007
- Descendant · 3 generations on · 10 of its ownK093779 Clearpath UgiEasyglide, Ltd. · 2010
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K032688Colonosight Model 510BSightline Technologies, Ltd. · 2004 · cites it directly38descendants
- K091305ClearpathEasyglide, Ltd. · 2009 · 2 generations on13descendants
- K052930Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006 · cites it directly13descendants
- K070622Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007 · cites it directly12descendants
- K093779Clearpath UgiEasyglide, Ltd. · 2010 · 3 generations on10descendants
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 | K951579 | EC-3800TL, Video Colonoscope | Pentax Precision Instrument Corp. | 1996 | 1 |
| 0 (this device) | K961563 | EC-384OTL, Video Colonscope | Pentax Precision Instrument Corp. | 1996 | — |
| +1 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| +2 | K091305 | Clearpath | Easyglide, Ltd. | 2009 | — |
| +1 | K052930 | Navigator Endoscopy System | Neoguide Systems, Inc. | 2006 | — |
| +1 | K070622 | Neoguide Endoscopy System | Neoguide Systems, Inc. | 2007 | — |
| +3 | K093779 | Clearpath Ugi | Easyglide, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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.
Planning a device in FDF? 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K951579 | EC-3800TL, Video ColonoscopeSummary page 1…840TL, Video Colonoscope Classification Name: Colonoscope, Gastro- Urology (78FDF), 876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. EC-3800TL, Video Colonoscope Pentax K951579 2. EPM-3300, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The EC-3840TL, Video Colonoscope, must be used with a Video… | 1996 |
| * | K934918 | Epm-3300 Video ProcessorSummary page 1…: Colonoscope, Gastro- Urology (78FDF), 876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. EC-3800TL, Video Colonoscope Pentax K951579 2. EPM-3300, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The EC-3840TL, Video Colonoscope, must be used with a Video Processor (a software controlled device). Th… | 1994 |
What descends from it? (39)
See all 393 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a 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.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K032688 (Sightline Technologies, Ltd., 2004) has gone furthest, with 38 descendants of its own.
- 3 other devices also cite its predicate K951579.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 4 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
The EC-3840TL, Video Colonscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel. The instrument is introduced per rectally 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/K961563 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961563: EC-384OTL, Video Colonscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961563
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