510(k) · Cleared
ClearedZeiss Confocal Laser Scanning Ophthalmoscope (Clso)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss, Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Dec 23, 1991 after a 194-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 18 later devices descend from it.
- Decided
- Dec 23, 1991
- Review
- 194 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK912581 Zeiss Confocal Laser Scanning Ophthalmoscope (Clso)Carl Zeiss, Inc. · 1991
- Descendant · cites it directly · 16 of its ownK042740 Isc-1000 Pentax Confocal Laser SystemPentax Medical Company · 2004
- Descendant · cites it directly · 15 of its ownK042741 EC-3870CILK, Confocal Video ColonoscopePentax Medical Company · 2004 · Recalled
- Descendant · 2 generations on · 13 of its ownK061666 Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and…Mauna Kea Technologies · 2006
- Descendant · 2 generations on · 13 of its ownK051585 F-400 SystemMauna Kea Technologies · 2005
- Descendant · 3 generations on · 12 of its ownK111047 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc. · 2011
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K042740Isc-1000 Pentax Confocal Laser SystemPentax Medical Company · 2004 · cites it directly16descendants
- K042741EC-3870CILK, Confocal Video ColonoscopePentax Medical Company · 2004 · cites it directly15descendants
- K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies · 2006 · 2 generations on13descendants
- K051585F-400 SystemMauna Kea Technologies · 2005 · 2 generations on13descendants
- K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc. · 2011 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912581 | Zeiss Confocal Laser Scanning Ophthalmoscope (Clso) | Carl Zeiss, Inc. | 1991 | — |
| +1 | K042740 | Isc-1000 Pentax Confocal Laser System | Pentax Medical Company | 2004 | — |
| +1 | K042741 | EC-3870CILK, Confocal Video Colonoscope | Pentax Medical Company | 2004 | 2 |
| +2 | K061666 | Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex | Mauna Kea Technologies | 2006 | — |
| +2 | K051585 | F-400 System | Mauna Kea Technologies | 2005 | — |
| +3 | K111047 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (18)
See all 182 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?
- Of its descendants, K042740 (Pentax Medical Company, 2004) has gone furthest, with 16 descendants of its own.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HLI
112in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HLI
2in 2024
MAUDE reports naming product code HLI, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 36 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 4 | 112 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 2 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K912581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912581: Zeiss Confocal Laser Scanning Ophthalmoscope (Clso).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912581
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026