510(k) · Cleared
ClearedCellvizio 100 Series System 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 Oct 23, 2015 as substantially equivalent to K013165 (Circon Acmi, 2002) after a 133-day review. Its family tree reaches back 2 generations to 1996. 8 later devices descend from it.
- Decided
- Oct 23, 2015
- Review
- 133 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955845 (1996). 6 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK955845 LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod LensSurgical Image Laboratories, Inc. · 1996
- 1 generation backK013165 Usa Series LaparoscopesCircon Acmi · 2002
- This deviceK151593 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015
- Descendant · cites it directly · 7 of its ownK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016
- 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- K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies · 2016 · 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 |
|---|---|---|---|---|---|
| −2 | K955845 | LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod Lens | Surgical Image Laboratories, Inc. | 1996 | — |
| −1 | K013165 | Usa Series Laparoscopes | Circon Acmi | 2002 | — |
| 0 (this device) | K151593 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015 | — |
| +1 | K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal… | Mauna Kea Technologies | 2016 | — |
| +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 |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (1)
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 |
|---|---|---|---|
| * | K013165 | Usa Series LaparoscopesSummary page 4…egulation: OWN / GCJ 21 CFR 876.1500 Classification: Class II Predicate Device: • Circon’s USA Series™ Laparoscope has been cleared with K013165 Reference Devices: • The Cellvizio 100 Series System with Confocal Miniprobes cleared via K111047. • The CystoFlex™ UHD R… | 2002 |
| † | K111047 | Cellvizio 100 Series System with Confocal Miniprobes | 2011 |
| † | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | 2014 |
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 19 years and passes through 3 companies; a new generation was cleared every 13.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K160416 (Mauna Kea Technologies, 2016) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K013165.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Cellvizio® 100 Series System with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.
CelioFlex™ UHD 5 Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151593: Cellvizio 100 Series System 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/K151593
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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