510(k) · Cleared
ClearedCentervue Macular Integrity Assessment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centervue S.P.A. · HLI Ophthalmoscope, Ac-Powered
Cleared on Apr 23, 2014 as substantially equivalent to K092187 (Centervue S.P.A., 2010) after a 133-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 23, 2014
- Review
- 133 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941234 (1995). 8 ancestors in all, the oldest K810880 (1981). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 5 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 4 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 3 generations backK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
- 2 generations backK061768 MP-1 MicroperimeterNidek Technologies Srl · 2006
- 1 generation backK092187 Maia, Model 1Centervue S.P.A. · 2010
- This deviceK133758 Centervue Macular Integrity AssessmentCentervue S.P.A. · 2014
- Descendant · cites it directly · 1 of its ownK150320 CompassCentervue S.P.A. · 2015
- Descendant · 2 generations on · 0 of its ownK243504 Maia (AHMACME001)Centervue S.P.A. · 2025
- Descendant · cites it directly · 0 of its ownK153181 MAIACentervue S.P.A. · 2016
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 |
|---|---|---|---|---|---|
| −6 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −5 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −4 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −3 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
| −2 | K061768 | MP-1 Microperimeter | Nidek Technologies Srl | 2006 | — |
| −1 | K092187 | Maia, Model 1 | Centervue S.P.A. | 2010 | — |
| 0 (this device) | K133758 | Centervue Macular Integrity Assessment | Centervue S.P.A. | 2014 | — |
| +1 | K150320 | Compass | Centervue S.P.A. | 2015 | — |
| +2 | K243504 | Maia (AHMACME001) | Centervue S.P.A. | 2025 | — |
| +1 | K153181 | MAIA | Centervue S.P.A. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K092187 | Maia, Model 1Summary page 7…is concluded that revised design of MAIA TM is substantially equivalent to the identified predicate device, the original design of MAIA TM cleared under K092187, which is already in interstate commerce within the USA. Special 510(k) for MAJA… | 2010 |
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K150320 (Centervue S.P.A., 2015) 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. 2014, this device’s year, is highlighted.
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?
The Macular Integrity Assessment (MAIAW) is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing Infrared retinal Imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133758: Centervue Macular Integrity Assessment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133758
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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