510(k) · Cleared
Recalled · Class II · 2017Ifusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optovue, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jul 3, 2013 as substantially equivalent to K121739 (Optovue, Inc., 2013) and 1 other predicate after a 113-day review. Its family tree reaches back 8 generations to 1995. It has been recalled once.
- Decided
- Jul 3, 2013
- Review
- 113 days
- Class
- Class II
- Product code
- HKI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K941234 (1995). 30 ancestors in all, the oldest K810880 (1981). No later device cites it as a predicate yet.
- Root · 8 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 7 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 6 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 5 generations backK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
- 4 generations backK061768 MP-1 MicroperimeterNidek Technologies Srl · 2006
- 3 generations backK070231 ORIONNidek Technologies Srl · 2007
- 2 generations backK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- 1 generation backK122572 Icam Fundus CameraOptovue, Inc. · 2013
- This deviceK130656 IfusionOptovue, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −7 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −6 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −5 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
| −4 | K061768 | MP-1 Microperimeter | Nidek Technologies Srl | 2006 | — |
| −3 | K070231 | ORION | Nidek Technologies Srl | 2007 | — |
| −2 | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| −1 | K122572 | Icam Fundus Camera | Optovue, Inc. | 2013 | — |
| 0 (this device) | K130656 | Ifusion | Optovue, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 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 12.7 · 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? (2)
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 |
|---|---|---|---|
| * | K121739 | Ivue with Normative DatabaseSummary page 1…a (21 C.F.R. § 886.1120) Classification: Class II Product Code: HKI OBO Predicate Devices 1. 510(k) K121739 iVue with Normative Database - Optovue 2. 510(k) K122572 iCamn Fundus Camera - Optovue Purpose of the Special 510(k) n… | 2013 |
| * | K122572 | Icam Fundus CameraSummary page 1…I Product Code: HKI OBO Predicate Devices 1. 510(k) K121739 iVue with Normative Database - Optovue 2. 510(k) K122572 iCamn Fundus Camera - Optovue Purpose of the Special 510(k) notice iFusion is a combination of the cleared iVue with NDB… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2017 | Class II | Z-0009-2018 | Other | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 30 ancestors have a recall of any class.
- 5 other devices also cite its predicate K121739.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The iFusion connects the iCam (K122572) and iVue (K121739) devices via a sliding bracket mechanism (iShuttle), to facilitate switching between the two devices. The iShuttle provides position adjustment ability of the iCam or iVue device during use.
The iFusion interfaces with the iCam and iVue devices to enable the operation of the iCam and iVue devices from one computer unit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130656: Ifusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130656
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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