510(k) · Cleared
ClearedCystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) 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 May 20, 2016 as substantially equivalent to K141358 (Mauna Kea Technologies, 2014) and 1 other predicate after a 94-day review. Its family tree reaches back 9 generations to 1995. 1 of the 79 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- May 20, 2016
- Review
- 94 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K935844 (1995). 71 ancestors in all, the oldest K822846 (1982). 7 later devices descend from it, 1 citing it directly. 1 of the 79 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 5 generations between
- 3 generations backK123676 Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013
- 2 generations backK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- 1 generation backK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
- This deviceK160416 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
- Descendant · 3 generations on · 0 of its ownK241275 Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA · 2024
Show all 9 generations
- Root · 9 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 8 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 7 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 6 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 5 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 4 generations backK092359 Echo Tip Ultra High Definition Ultrasound Access Needle, Model…Cook Ireland, Ltd. · 2009 · Recalled
- 3 generations backK123676 Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013
- 2 generations backK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- 1 generation backK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
- This deviceK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…5 generations back · 2003
Most influential descendants
Showing 5 of 7 · See all- 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
- K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −8 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −7 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −6 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −5 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −4 | K092359 | Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A | Cook Ireland, Ltd. | 2009 | 1 |
| −3 | K123676 | Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes | Mauna Kea Technologies | 2013 | — |
| −2 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| −1 | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | Mauna Kea Technologies | 2014 | — |
| 0 (this device) | 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 | — |
| +3 | K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3) | Samantree Medical SA | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 1 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K141358 | Cellvizio 100 Series with System Confocal MiniprobesSummary page 4…ng Product Code/ Regulation: OWN / GCJ 21 CFR 876.1500 Classification: Class II Predicate Devices: • CystoFlex UHD R has been cleared via K141358 • CelioFlex UHD 5 has been cleared via K151593 Reference Devices: • Cellvizio 100 Series F700-V2 system with Confocal… | 2014 |
| * | K151593 | Cellvizio 100 Series System with Confocal MiniprobesSummary page 4…76.1500 Classification: Class II Predicate Devices: • CystoFlex UHD R has been cleared via K141358 • CelioFlex UHD 5 has been cleared via K151593 Reference Devices: • Cellvizio 100 Series F700-V2 system with Confocal Miniprobes has been cleared via K133466. The na… | 2015 |
| † | K133466 | Cellvizio 100 Series System with Confocal Miniprobes (TM) | 2014 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172844 | Cellvizio 100 Series System with Confocal Miniprobes | 2017 | 6 |
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 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 21 of the 71 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K172844 (Mauna Kea Technologies, 2017) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K141358.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.
CelioFlex™ UHD 5-C 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.
CystoFlex™ UHD R-C Confocal Miniprobe can be used within anatomical tracts, i.e., urinary, including, but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) 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/K160416
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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