510(k) · Cleared
ClearedCellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daniel & Daniel Consulting · OWN Confocal Optical Imaging
Cleared on Feb 25, 2014 as substantially equivalent to K111047 (Mauna Kea Technologies, Inc., 2011) and 4 other predicates after a 208-day review. Its family tree reaches back 7 generations to 1995. 1 of the 73 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Feb 25, 2014
- Review
- 208 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K935844 (1995). 62 ancestors in all, the oldest K822846 (1982). 10 later devices descend from it, 2 citing it directly. 1 of the 73 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 6 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 5 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 4 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 3 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 2 generations backK092359 Echo Tip Ultra High Definition Ultrasound Access Needle, Model…Cook Ireland, Ltd. · 2009 · Recalled
- 1 generation backK123676 Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013
- This deviceK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · cites it directly · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
- Descendant · 2 generations on · 7 of its ownK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016
- Descendant · cites it directly · 7 of its ownK150831 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015
- Descendant · 2 generations on · 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
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…4 generations back · 2003
Most influential descendants
Showing 5 of 10 · See all- K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · cites it directly9descendants
- K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies · 2016 · 2 generations on7descendants
- K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015 · cites it directly7descendants
- K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2017 · 2 generations on6descendants
- K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies · 2019 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −6 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −5 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −4 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −3 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −2 | K092359 | Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A | Cook Ireland, Ltd. | 2009 | 1 |
| −1 | K123676 | Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes | Mauna Kea Technologies | 2013 | — |
| 0 (this device) | 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 | — |
| +2 | K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal… | Mauna Kea Technologies | 2016 | — |
| +1 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015 | — |
| +2 | 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 | — |
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 | 5 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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 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? (5)
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 |
|---|---|---|---|
| * | K111047 | Cellvizio 100 Series System with Confocal MiniprobesSummary page 1…ation: Class 11 Predicate Devices: " Regarding the Cellvizic Confocal Imaging System, the Cellvizio 100 SereSTM System has been cleared in K111047. " Regardingrthe Imaging System and the Confocal Miniprobes equivalence, the Uroflex mB and CystoFlex MF Confocal Mi… | 2011 |
| * | K123676 | Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesSummary page 1…oflex mB and CystoFlex MF Confocal Miniprobes are identical in design and materials to the AQ-Flex 19 Confocal Miniprobe, most recently cleared through K123676. * Regarding the compatibility of the access during urological procedures and the visualization and examination o… | 2013 |
| * | K043022 | Stryker Flexible CystonephroscopeSummary page 1…ogical procedures and the visualization and examination of the urinary tract, the following cystoscopes and ureteroscope: 1. Flexible CystoNephroscope (K043022 from Stryker) 2. Cysto-Urethroscope "E-Line' (K011496 from Richard Wolf) 3. PolyScope Flexible Endloscope (K091… | 2005 |
| * | K011496 | Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and…Summary page 1…n of the urinary tract, the following cystoscopes and ureteroscope: 1. Flexible CystoNephroscope (K043022 from Stryker) 2. Cysto-Urethroscope "E-Line' (K011496 from Richard Wolf) 3. PolyScope Flexible Endloscope (K091962 from Lumenis, Inc.) Confidential Informnation === Page… | 2001 |
| * | K091962 | Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…Summary page 1…1. Flexible CystoNephroscope (K043022 from Stryker) 2. Cysto-Urethroscope "E-Line' (K011496 from Richard Wolf) 3. PolyScope Flexible Endloscope (K091962 from Lumenis, Inc.) Confidential Informnation… | 2009 |
What descends from it? (10)
2 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 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 21 of the 62 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K141358 (Mauna Kea Technologies, 2014) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K111047.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 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.
The UroFlex™ B and CystoFlex™ F Confocal Miniprobes 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.
Confocal Miniprobes™ Endoscope or accessory
UroFlex™ B Cystoscope or ureteroscope with operating channel internal diameter ≥ 1.0mm (3 Fr)
CystoFlex™ F Flexible Cystoscope with operating channel internal diameter ≥ 1.0mm (3 Fr)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132389
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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