510(k) · Cleared
ClearedCellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mauna Kea Technologies · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 24, 2006 as substantially equivalent to K042740 (Pentax Medical Company, 2004) and 2 other predicates after a 71-day review. Its family tree reaches back 4 generations to 1993. 1 of the 33 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.
- Decided
- Aug 24, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K926514 (1993). 19 ancestors in all, the oldest K822846 (1982). 13 later devices descend from it, 2 citing it directly. 1 of the 33 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 3 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 2 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 1 generation backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- This deviceK061666 Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and…Mauna Kea Technologies · 2006
- Descendant · cites it directly · 12 of its ownK111047 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc. · 2011
- Descendant · 2 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 2 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
- Descendant · 3 generations on · 7 of its ownK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016
- Descendant · 2 generations on · 7 of its ownK150831 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…2 generations back · 2003
Most influential descendants
Showing 5 of 13 · See all- K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc. · 2011 · cites it directly12descendants
- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 2 generations on10descendants
- K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 2 generations on9descendants
- K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies · 2016 · 3 generations on7descendants
- K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −3 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −2 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −1 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| 0 (this device) | K061666 | Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex | Mauna Kea Technologies | 2006 | — |
| +1 | K111047 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies, Inc. | 2011 | — |
| +2 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +2 | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | Mauna Kea Technologies | 2014 | — |
| +3 | K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal… | Mauna Kea Technologies | 2016 | — |
| +2 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 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? (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 |
|---|---|---|---|
| * | K042740 | Isc-1000 Pentax Confocal Laser SystemSummary page 1…veoflex) Classification Name: Endoscope and/or Accessories 10.3 Predicate Device(s) Information Pentax Confocal Laser System, K042740 Pentax EC-3870CILK Confocal Video Colonoscope, K042741 superDimension Bronchus, K042438… | 2004 |
| * | K042741 | EC-3870CILK, Confocal Video ColonoscopeSummary page 1…ies 10.3 Predicate Device(s) Information Pentax Confocal Laser System, K042740 Pentax EC-3870CILK Confocal Video Colonoscope, K042741 superDimension Bronchus, K042438 10.4 Device Description The Cellvizio®(-GI, -LUNG) wit… | 2004 |
| * | K042438 | Superdimension/BronchusSummary page 1…Pentax Confocal Laser System, K042740 Pentax EC-3870CILK Confocal Video Colonoscope, K042741 superDimension Bronchus, K042438 10.4 Device Description The Cellvizio®(-GI, -LUNG) with Confocal MiniprobeT ' (Coloflex,… | 2004 |
| † | K051585 | F-400 System | 2005 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K111047 (Mauna Kea Technologies, Inc., 2011) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K042740.
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 Cellvizio® (-GI, -LUNG) with Confocal MiniprobeTM (Coloflex, Gastroflex, Alveoflex) is a confocal laser imaging system with fiber optic probes that is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or pulmonary, accessed by the endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061666 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061666: Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061666
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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