510(k) · Cleared
ClearedMaia, Model 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centervue S.P.A. · HPT Perimeter, Automatic, Ac-Powered
Cleared on May 27, 2010 as substantially equivalent to K023719 (Nidek Technologies Srl, 2002) and 2 other predicates after a 310-day review. Its family tree reaches back 5 generations to 1995. 4 later devices descend from it.
- Decided
- May 27, 2010
- Review
- 310 days
- Class
- Class I
- Product code
- HPT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K941234 (1995). 7 ancestors in all, the oldest K810880 (1981). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 4 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 3 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 2 generations backK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
- 1 generation backK061768 MP-1 MicroperimeterNidek Technologies Srl · 2006
- This deviceK092187 Maia, Model 1Centervue S.P.A. · 2010
- Descendant · cites it directly · 3 of its ownK133758 Centervue Macular Integrity AssessmentCentervue S.P.A. · 2014
- Descendant · 2 generations on · 1 of its ownK150320 CompassCentervue S.P.A. · 2015
- Descendant · 3 generations on · 0 of its ownK243504 Maia (AHMACME001)Centervue S.P.A. · 2025
- Descendant · 2 generations on · 0 of its ownK153181 MAIACentervue S.P.A. · 2016
Most influential descendants
Showing 4 of 4 · See all- K133758Centervue Macular Integrity AssessmentCentervue S.P.A. · 2014 · cites it directly3descendants
- K150320CompassCentervue S.P.A. · 2015 · 2 generations on1descendant
- K243504Maia (AHMACME001)Centervue S.P.A. · 2025 · 3 generations on0descendants
- K153181MAIACentervue S.P.A. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −4 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −3 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −2 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
| −1 | K061768 | MP-1 Microperimeter | Nidek Technologies Srl | 2006 | — |
| 0 (this device) | K092187 | Maia, Model 1 | Centervue S.P.A. | 2010 | — |
| +1 | K133758 | Centervue Macular Integrity Assessment | Centervue S.P.A. | 2014 | — |
| +2 | K150320 | Compass | Centervue S.P.A. | 2015 | — |
| +3 | K243504 | Maia (AHMACME001) | Centervue S.P.A. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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 HPT? 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? (3)
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 |
|---|---|---|---|
| * | K023719 | MP-1 Micro PerimeterSummary page 2…ction: Predicate Device I 510(k) Holder 510(k) No. Date cleared * MP-1 MICROPERIMETER Nidek Technologies Sri K023719 December 2 3 d 2002 MP-1 MICROPERIMETER Nidek Technologies SrI K061768 September 2gth 2006… | 2002 |
| * | K061768 | MP-1 MicroperimeterSummary page 2…* MP-1 MICROPERIMETER Nidek Technologies Sri K023719 December 2 3 d 2002 MP-1 MICROPERIMETER Nidek Technologies SrI K061768 September 2gth 2006 CIRRUS HD-OCT(*) Carl Zeiss Meditec Inc. K063378 Ianuary 26th 2007… | 2006 |
| * | K063378 | Cirrus HD-Oct, Model 4000Summary page 2…MP-1 MICROPERIMETER Nidek Technologies SrI K061768 September 2gth 2006 CIRRUS HD-OCT(*) Carl Zeiss Meditec Inc. K063378 Ianuary 26th 2007 ()onlywith regard to its retinal imaging sub-system CLINICAL EVALUATION Clinical… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133758 | Centervue Macular Integrity Assessment | 2014 | 3 |
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 15 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K133758 (Centervue S.P.A., 2014) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K023719.
How does its category compare?
All HPT devicesHPT Perimeter, Automatic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HPT
2in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · HPT
Too few HPT 510(k)s in any year since 2007 to give a median.
Recalls per year · HPT
No recall names HPT since 2007.
Adverse event reports per year · HPT
1in 2023
MAUDE reports naming product code HPT, 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 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 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 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Macular Integrity Assessment (MAIA™) is indicated 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/K092187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092187: Maia, Model 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092187
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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