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, Inc. · OWN Confocal Optical Imaging
Cleared on Aug 8, 2011 as substantially equivalent to K051585 (Mauna Kea Technologies, 2005) and 1 other predicate after a 115-day review. Its family tree reaches back 5 generations to 1993. 1 of the 34 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Aug 8, 2011
- Review
- 115 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K926514 (1993). 21 ancestors in all, the oldest K822846 (1982). 12 later devices descend from it, 5 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 4 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 3 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 2 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 1 generation backK051585 F-400 SystemMauna Kea Technologies · 2005
- This deviceK111047 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc. · 2011
- Descendant · cites it directly · 10 of its ownK132389 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 · cites it directly · 7 of its ownK133466 Cellvizio 100 Series System with Confocal Miniprobes (TM)Mauna Kea Technologies · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…3 generations back · 2003
Most influential descendants
Showing 5 of 12 · See all- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · cites it directly10descendants
- 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
- K133466Cellvizio 100 Series System with Confocal Miniprobes (TM)Mauna Kea Technologies · 2014 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −4 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −3 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −2 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −1 | K051585 | F-400 System | Mauna Kea Technologies | 2005 | — |
| 0 (this device) | K111047 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies, Inc. | 2011 | — |
| +1 | 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 | — |
| +1 | K133466 | Cellvizio 100 Series System with Confocal Miniprobes (TM) | Mauna Kea Technologies | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 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? (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 |
|---|---|---|---|
| * | K051585 | F-400 SystemSummary page 2…510(k) No. Date Celivizios F-400 System Ma u na KRe a K051585 September 6. Technologies… | 2005 |
| * | K061666 | Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexSummary page 3…tissues in anatomical tracts, i.e. gastrointestinal or respiratory, accessed through an endoscope. The intended use of the device has not changed since the K051585 and K061666 clearances. F. Indications for use The Cellvizio* 100 Series System with Confocal Miniprobes" is a confocal laser system with f… | 2006 |
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and… | 2014 | 10 |
| K141358 | Cellvizio 100 Series with System Confocal Miniprobes | 2014 | 9 |
| K150831 | Cellvizio 100 Series System with Confocal Miniprobes | 2015 | 7 |
| K133466 | Cellvizio 100 Series System with Confocal Miniprobes (TM) | 2014 | 7 |
| 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 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 21 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K132389 (Daniel & Daniel Consulting, 2014) has gone furthest, with 10 descendants of its own.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal or respiratory, accessed by an endoscope or endoscopic accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111047: 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/K111047
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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