510(k) · Cleared
ClearedRetina Angiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heidelberg Engineering · HLI Ophthalmoscope, Ac-Powered
Cleared on Nov 14, 1994 after a 74-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 137 later devices descend from it.
- Decided
- Nov 14, 1994
- Review
- 74 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
137 later devices descend from it, 1 citing it directly.
- This deviceK944261 Retina AngiographHeidelberg Engineering · 1994
- Descendant · cites it directly · 136 of its ownK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 134 of its ownK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 133 of its ownK061871 Leica Model FL800Leica Microsystems, Inc. · 2006
- Descendant · 2 generations on · 131 of its ownK071037 Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 131 of its ownK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 137 · See all- K042961Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · cites it directly136descendants
- K060867Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · 2 generations on134descendants
- K061871Leica Model FL800Leica Microsystems, Inc. · 2006 · 2 generations on133descendants
- K071037Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc. · 2007 · 2 generations on131descendants
- K063345Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · 2 generations on131descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| +1 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| +2 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| +2 | K061871 | Leica Model FL800 | Leica Microsystems, Inc. | 2006 | — |
| +2 | K071037 | Spy Intra-Operative Imaging System, Model SP2000 | Novadaq Technologies, Inc. | 2007 | 1 |
| +2 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 10 | 0 |
| 2022 | 12 | 0 |
| 2023 | 15 | 0 |
| 2024 | 14 | 0 |
| 2025 | 16 | 0 |
| 2026 | 18 | 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? (137)
See all 1371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042961 | Spy Intra-Operative Imaging System: SP2000 | 2005 | 136 |
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, K042961 (Novadaq Technologies, Inc., 2005) has gone furthest, with 136 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/K944261 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944261: Retina Angiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944261
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