510(k) · Cleared
ClearedAlleye
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculocare Medical AG · HOQ Grid, Amsler
Cleared on Jun 27, 2018 as substantially equivalent to K143211 (Vital Art and Science Incorporated, 2015) after an 83-day review. Its family tree reaches back 12 generations to 1987. 1 later device descends from it.
- Decided
- Jun 27, 2018
- Review
- 83 days
- Class
- Class I
- Product code
- HOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K864318 (1987). 41 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations between
- 3 generations backK091579 Foresee HomeNotal Vision, Ltd. · 2009
- 2 generations backK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
- 1 generation backK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
- This deviceK180895 AlleyeOculocare Medical AG · 2018
- Descendant · cites it directly · 0 of its ownK203594 EyeCTesterNeuro-Eye Diagnostic Systems, LLC · 2022
Show all 12 generations
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 11 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 10 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 9 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 8 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 7 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 6 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 5 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 4 generations backK071564 Motiva Monitor Device Connectivity, Model# 453564036921Philips Medical Systems · 2007
- 3 generations backK091579 Foresee HomeNotal Vision, Ltd. · 2009
- 2 generations backK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
- 1 generation backK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
- This deviceK180895 AlleyeOculocare Medical AG · 2018
Most influential descendants
Showing 1 of 1 · See all- K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −11 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −10 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −9 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −8 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −7 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −6 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −5 | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| −4 | K071564 | Motiva Monitor Device Connectivity, Model# 453564036921 | Philips Medical Systems | 2007 | — |
| −3 | K091579 | Foresee Home | Notal Vision, Ltd. | 2009 | — |
| −2 | K121738 | Myvisiontrack (TM) | Vital Art and Science Incorporated | 2013 | — |
| −1 | K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | 2015 | — |
| 0 (this device) | K180895 | Alleye | Oculocare Medical AG | 2018 | — |
| +1 | K203594 | EyeCTester | Neuro-Eye Diagnostic Systems, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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 HOQ? 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 |
|---|---|---|---|
| * | K143211 | myVision Track Model 005Summary page 5…IFICATION Alleye is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K143211 myVisionTrack Model 0005 / Vital Art and Science, LLC SUMMARY OF NON‐CLINICAL TESTING No FDA performan… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203594 | EyeCTester | 2022 | 0 |
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?
- The line of descent spans 31 years and passes through 10 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 41 ancestors have a recall of any class.
- Of its descendants, K203594 (Neuro-Eye Diagnostic Systems, LLC, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HOQ devicesHOQ Grid, Amsler: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HOQ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HOQ
Too few HOQ 510(k)s in any year since 2007 to give a median.
Recalls per year · HOQ
No recall names HOQ since 2007.
Adverse event reports per year · HOQ
No MAUDE report names HOQ since 2007.
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 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 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 | — |
What is it indicated for?
The Alleye is a mobile medical software application indicated for the detection and characterization of metamorphopsia, a visual distortion, in patients with age-related macular degeneration (AMD) and as an aid in the monitoring of the progression of this condition in respect of metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180895: Alleye.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180895
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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