510(k) · Cleared
Recalled · Class II · 2016EC-3870CILK, Confocal Video Colonoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Medical Company · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 19, 2004 as substantially equivalent to K951574 (Pentax Precision Instrument Corp., 1996) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1982. 15 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 19, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K822846 (1982). 5 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- 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 deviceK042741 EC-3870CILK, Confocal Video ColonoscopePentax Medical Company · 2004
- Descendant · cites it directly · 13 of its ownK061666 Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and…Mauna Kea Technologies · 2006
- Descendant · cites it directly · 13 of its ownK051585 F-400 SystemMauna Kea Technologies · 2005
- Descendant · 2 generations on · 12 of its ownK111047 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc. · 2011
- Descendant · 3 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 3 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies · 2006 · cites it directly13descendants
- K051585F-400 SystemMauna Kea Technologies · 2005 · cites it directly13descendants
- K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc. · 2011 · 2 generations on12descendants
- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 3 generations on10descendants
- K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 3 generations on9descendants
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) | K042741 | EC-3870CILK, Confocal Video Colonoscope | Pentax Medical Company | 2004 | — |
| +1 | K061666 | Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex | Mauna Kea Technologies | 2006 | — |
| +1 | K051585 | F-400 System | Mauna Kea Technologies | 2005 | — |
| +2 | K111047 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies, Inc. | 2011 | — |
| +3 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +3 | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | Mauna Kea Technologies | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | K951574 | EC-3800L, Video ColonoscopeSummary page 1…nufacturer IPMN# EC-3800L, Video Colonoscope Pentax Corporation K95 1574 Zeiss CLSO Confocal Laser Scanner Ophthalmoscope Carl Zeiss, Inc. K9 125… | 1996 |
| * | K912581 | Zeiss Confocal Laser Scanning Ophthalmoscope (Clso)Summary page 1…Corporation K95 1574 Zeiss CLSO Confocal Laser Scanner Ophthalmoscope Carl Zeiss, Inc. K9 12581 Device Description: The EC-3S7OCILK, Confocal Video Colonoscope, must be used with a Pentax Video Processor (software controlled… | 1991 |
What descends from it? (15)
See all 152 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2016 | Class II | Z-2069-2016 | 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. |
| Apr 6, 2016 | Class II | Z-2276-2016 | Device Design | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 13.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K061666 (Mauna Kea Technologies, 2006) has gone furthest, with 13 descendants of its own.
- 7 other devices also cite its predicate K951574.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The EC-3870CILK, Confocal Video Colonoscope, is intended to provide optical visualization (via a video monitor), (confocal) microscopic visualization of (via a video monitor), 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 as stated in the FDA summary.
https://510kreport.com/device/K042741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042741: EC-3870CILK, Confocal Video Colonoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042741
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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