510(k) · Cleared
ClearedNerve Fiber Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Jul 18, 1994 after a 103-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jul 18, 1994
- Review
- 103 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK941705 Nerve Fiber AnalyzerCarl Zeiss Meditec, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK082016 GDX VCC with Ecc SoftwareCarl Zeiss Meditec, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK093521 GdxproCarl Zeiss Meditec, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK964137 Rta Retinal Thickness AnalyzerTalia Technology, Ltd. · 1997
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941705 | Nerve Fiber Analyzer | Carl Zeiss Meditec, Inc. | 1994 | — |
| +1 | K082016 | GDX VCC with Ecc Software | Carl Zeiss Meditec, Inc. | 2009 | — |
| +2 | K093521 | Gdxpro | Carl Zeiss Meditec, Inc. | 2009 | — |
| +1 | K964137 | Rta Retinal Thickness Analyzer | Talia Technology, Ltd. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2009 | 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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 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, K082016 (Carl Zeiss Meditec, Inc., 2009) has gone furthest, with 1 descendant 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/K941705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941705: Nerve Fiber Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941705
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