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 Apr 11, 2022 as substantially equivalent to K210265 (Visionsense, Ltd., 2021) after a 52-day review. Its family tree reaches back 20 generations to 1994. 1 later device descends from it.
- Decided
- Apr 11, 2022
- Review
- 52 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K930667 (1994). 89 ancestors in all, the oldest K811390 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 20 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 16 generations between
- 3 generations backK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
- 2 generations backK191851 VS3-IRMedtronic · 2019
- 1 generation backK210265 VS3 Iridium SytemVisionsense, Ltd. · 2021
- This deviceK220477 Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies · 2022
- Descendant · cites it directly · 0 of its ownK251852 cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775…VPIX Medical, Inc. · 2026
Show all 20 generations
- Root · 20 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 19 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 18 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 17 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 16 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 15 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 14 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 13 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 12 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 11 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 10 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 9 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 8 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 7 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 6 generations backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- 5 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- 4 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 3 generations backK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
- 2 generations backK191851 VS3-IRMedtronic · 2019
- 1 generation backK210265 VS3 Iridium SytemVisionsense, Ltd. · 2021
- This deviceK220477 Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies · 2022
Most influential descendants
Showing 1 of 1 · See all- K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −19 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −18 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −17 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −16 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −15 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −14 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −13 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −12 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −11 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −10 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −9 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −8 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −7 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −6 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
| −5 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
| −4 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | — |
| −3 | K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2018 | — |
| −2 | K191851 | VS3-IR | Medtronic | 2019 | — |
| −1 | K210265 | VS3 Iridium Sytem | Visionsense, Ltd. | 2021 | — |
| 0 (this device) | K220477 | Cellvizio 100 series system with confocal Miniprobes | Mauna Kea Technologies | 2022 | — |
| +1 | K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | VPIX Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 9 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K210265 | VS3 Iridium SytemSummary page 5…e/ Regulation: OWN / GCJ / GWG 21 CFR 876.1500, 21 CFR 882.1480 Classification: Class II Predicate Device: VS3 Iridium System, Visionsense Ltd., K210265. Reference Device: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies, K191144. Indications for Use: Th… | 2021 |
| † | K191144 | Cellvizio 100 Series System with Confocal Miniprobes | 2020 |
| † | K172844 | Cellvizio 100 Series System with Confocal Miniprobes | 2017 |
| † | K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | 2026 | 0 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 26 of the 89 ancestors have a recall of any class.
- Of its descendants, K251852 (VPIX Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K210265.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 including, but not limited to, the identification of cells, vessels and their organization or architecture. The Cellvizio® 100 Series System F400 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. Upon intravenous…
Read the full statement (373 words)
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 including, but not limited to, the identification of cells, vessels and their organization or architecture.
The Cellvizio® 100 Series System F400 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.
Upon intravenous administration and use of an ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence angiography.
Upon interstitial administration and use of ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging of tissues that have taken up the drug.
The GastroFlex™ (UHD, UHD-C) and ColoFlex™ (UHD, UHD-C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.
The AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
The AQ-Flex™ 19 (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope or endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA).
The CystoFlex™ (F, F-C, and UHD, UHD-C) and UroFlex™ B (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
The CelioFlex™ (UHD 5, UHD 5-C) Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
The CranioFlex™ (-, -C) Confocal Miniprobes™ are indicated to provide visualization within the central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220477: 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/K220477
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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