510(k) · Cleared
ClearedHumphrey Oct Scanner
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 Jun 21, 1996 after an 88-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Jun 21, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK961171 Humphrey Oct ScannerCarl Zeiss, Inc. · 1996
- Descendant · cites it directly · 17 of its ownK993357 IolmasterCarl Zeiss, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 16 of its ownK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- Descendant · 2 generations on · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- Descendant · 3 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K993357IolmasterCarl Zeiss, Inc. · 2000 · cites it directly17descendants
- K030393Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003 · 2 generations on16descendants
- K082891Lenstar, Model LS900Haag-Streit AG · 2009 · 2 generations on14descendants
- K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · 2 generations on10descendants
- K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961171 | Humphrey Oct Scanner | Carl Zeiss, Inc. | 1996 | — |
| +1 | K993357 | Iolmaster | Carl Zeiss, Inc. | 2000 | 4 |
| +2 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| +2 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| +2 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| +3 | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 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 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? (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 |
|---|---|---|---|
| * | — | OCT predicate device Named without a submission number |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993357 | Iolmaster | 2000 | 17 |
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, K993357 (Carl Zeiss, Inc., 2000) has gone furthest, with 17 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 | — |
What is it indicated for?
This device will be used in the same manner as all OCT scanner devices are used for two dimensional cross-sectional imaging of the posterior segment of the eye. It incorporates the original intended uses of our earlier claimed substantially equivalent products. It is used primarily for diagnosing and monitoring retinal diseases and disorders that manifest themselves in the posterior pole of the eye. Clinical studies with the OCT have demonstrated its effectiveness in detecting and quantifying the extent of macular edema, macular holes, retinal detachments and central serious chorioretinopathy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961171: Humphrey Oct Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961171
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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