510(k) · Cleared
ClearedORION
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek Technologies Srl · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Apr 24, 2007 as substantially equivalent to K023719 (Nidek Technologies Srl, 2002) and 2 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1995. 22 later devices descend from it.
- Decided
- Apr 24, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K941234 (1995). 6 ancestors in all, the oldest K810880 (1981). 22 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 deviceK070231 ORIONNidek Technologies Srl · 2007
- Descendant · cites it directly · 21 of its ownK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- Descendant · 2 generations on · 8 of its ownK142047 EIDONCentervue S.P.A. · 2014
- Descendant · 2 generations on · 8 of its ownK122572 Icam Fundus CameraOptovue, Inc. · 2013
- Descendant · 3 generations on · 3 of its ownK182199 NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019
- Descendant · 3 generations on · 2 of its ownK180526 Eidon FACentervue S.P.A. · 2018
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K101935Centervue Digital Retinography SystemCentervue S.P.A. · 2010 · cites it directly21descendants
- K142047EIDONCentervue S.P.A. · 2014 · 2 generations on8descendants
- K122572Icam Fundus CameraOptovue, Inc. · 2013 · 2 generations on8descendants
- K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019 · 3 generations on3descendants
- K180526Eidon FACentervue S.P.A. · 2018 · 3 generations on2descendants
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) | K070231 | ORION | Nidek Technologies Srl | 2007 | — |
| +1 | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| +2 | K142047 | EIDON | Centervue S.P.A. | 2014 | — |
| +2 | K122572 | Icam Fundus Camera | Optovue, Inc. | 2013 | — |
| +3 | K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | 2019 | — |
| +3 | K180526 | Eidon FA | Centervue S.P.A. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 HKI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HKI device
- #1 K253176 TearViewscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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…e Cleared MP-1 MICRO PERIMETER NIDEK TECHNOLOGIES SRL K023719 12 / 23 / 2002 K061768 09 / 2… | 2002 |
| * | K061768 | MP-1 MicroperimeterSummary page 2…MICRO PERIMETER NIDEK TECHNOLOGIES SRL K023719 12 / 23 / 2002 K061768 09 / 28/2006 NON-MYDRIATIC FUNDUS NIDEK, rNC K014274 04/17/20… | 2006 |
| * | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000Summary page 2…K061768 09 / 28/2006 NON-MYDRIATIC FUNDUS NIDEK, rNC K014274 04/17/2002 CAMERA, MODEL NM-1000 In further support of a substantial equivalence determination, Section 5 pro… | 2002 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101935 | Centervue Digital Retinography System | 2010 | 21 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K101935 (Centervue S.P.A., 2010) has gone furthest, with 21 descendants of its own.
- 4 other devices also cite its predicate K023719.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 2 | — | 0 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
ORION is an ophthalmic camera that is indicated for use in capturing images of the retina.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070231 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070231: ORION.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070231
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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