510(k) · Cleared
ClearedCellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mauna Kea Technologies · OWN Confocal Optical Imaging
Cleared on Sep 4, 2012 as substantially equivalent to K120208 (Mauna Kea Technologies, 2012) and 2 other predicates after a 54-day review. Its family tree reaches back 3 generations to 1997. 8 later devices descend from it.
- Decided
- Sep 4, 2012
- Review
- 54 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K963354 (1997). 4 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK963354 5 Star Medical EndoscopeFive Star Medical, Inc. · 1997
- 2 generations backK050403 Spyglass Direct Visulation ProbeBoston Scientific Corp · 2005
- 1 generation backK052194 Spyglass Direct Visualization Probe and OcularBoston Scientific Corp · 2005 · Recalled
- This deviceK122042 Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2012
- Descendant · cites it directly · 7 of its ownK150831 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015
- Descendant · cites it directly · 6 of its ownK172844 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2017
- Descendant · 2 generations on · 4 of its ownK183640 Cellvizio 100 Series Confocal laser Imaging systems and their…Mauna Kea Technologies · 2019
- Descendant · 2 generations on · 2 of its ownK191144 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2020
- Descendant · 3 generations on · 0 of its ownK243711 Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe…Wuxi Hisky Medical Technologies Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015 · cites it directly7descendants
- K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2017 · cites it directly6descendants
- K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies · 2019 · 2 generations on4descendants
- K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2020 · 2 generations on2descendants
- K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963354 | 5 Star Medical Endoscope | Five Star Medical, Inc. | 1997 | — |
| −2 | K050403 | Spyglass Direct Visulation Probe | Boston Scientific Corp | 2005 | — |
| −1 | K052194 | Spyglass Direct Visualization Probe and Ocular | Boston Scientific Corp | 2005 | 2 |
| 0 (this device) | K122042 | Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes | Mauna Kea Technologies | 2012 | — |
| +1 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015 | — |
| +1 | K172844 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2017 | — |
| +2 | K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal… | Mauna Kea Technologies | 2019 | — |
| +2 | K191144 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2020 | — |
| +3 | K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging… | Wuxi Hisky Medical Technologies Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 OWN? 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 OWN device
- #1 K231854 1788 4K Camera System with Advanced Imaging…score 24.9 · 24 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 |
|---|---|---|---|
| * | K120208 | Cellvizio 100 Series System and Cellvizio System with Confocal MiniprobesSummary page 1…ubmission) are identical in all engineering and design respects to the most recently cleared Cellvizio® 100 Series System and Cellvizion System with Confocal Miniprobes (K120208). The Boston Scientific SpyGlass Direct Visualization Probe cleared via K050403 and K052194 has been cited as an additional predi… | 2012 |
| * | K050403 | Spyglass Direct Visulation ProbeSummary page 1…ntly cleared Cellvizio® 100 Series System and Cellvizion System with Confocal Miniprobes (K120208). The Boston Scientific SpyGlass Direct Visualization Probe cleared via K050403 and K052194 has been cited as an additional predicate device. Device Description: The GastroFleX' TM M series of Confocal Minipr… | 2005 |
| * | K052194 | Spyglass Direct Visualization Probe and OcularSummary page 1…Cellvizio® 100 Series System and Cellvizion System with Confocal Miniprobes (K120208). The Boston Scientific SpyGlass Direct Visualization Probe cleared via K050403 and K052194 has been cited as an additional predicate device. Device Description: The GastroFleX' TM M series of Confocal Miniprobes are use… | 2005 |
What descends from it? (8)
2 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 15 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K150831 (Mauna Kea Technologies, 2015) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K120208.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OWN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWN
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWN
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWN
197in 2025
MAUDE reports naming product code OWN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 3 | 87 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 208 | 0 | 0 |
| 2015 | 5 | 163 | 0 | 1 |
| 2016 | 2 | — | 0 | 4 |
| 2017 | 5 | 87 | 0 | 12 |
| 2018 | 1 | — | 0 | 11 |
| 2019 | 7 | 81 | 0 | 59 |
| 2020 | 7 | 81 | 0 | 105 |
| 2021 | 4 | 104 | 0 | 312 |
| 2022 | 4 | 41 | 3 | 346 |
| 2023 | 6 | 69 | 0 | 164 |
| 2024 | 1 | — | 1 | 165 |
| 2025 | 3 | 196 | 0 | 197 |
| 2026 | 7 | 63 | 0 | — |
What is it indicated for?
The GastroFlex M series of Confocal Miniprobes are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122042: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122042
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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