510(k) · Cleared
ClearedAutokeratometer, Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeiss Humphrey System · HLQ Keratoscope, Ac-Powered
Cleared on Feb 12, 1979 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Feb 12, 1979
- Review
- 75 days
- Class
- Class I
- Product code
- HLQ
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK781994 Autokeratometer, InstrumentZeiss Humphrey System · 1979
- 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) | K781994 | Autokeratometer, Instrument | Zeiss Humphrey System | 1979 | — |
| +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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HLQ? 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 has not posted a summary or statement for it, so its predicates are not known.
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 HLQ devicesHLQ Keratoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLQ
FDA has decided no HLQ device since 2007.
Median 510(k) review, days · HLQ
Too few HLQ 510(k)s in any year since 2007 to give a median.
Recalls per year · HLQ
No recall names HLQ since 2007.
Adverse event reports per year · HLQ
1in 2017
MAUDE reports naming product code HLQ, 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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K781994 · printed Nov 4, 2026
Cite this page
510(k) Report. “K781994: Autokeratometer, Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K781994
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026