510(k) · Cleared
Recalled · Class II · 2014Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software NA Vis-EX
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 May 8, 2012 as substantially equivalent to K014274 (Nidek, Inc., 2002) and 1 other predicate after a 169-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 8, 2012
- Review
- 169 days
- Class
- Class II
- Product code
- HKI
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K941234 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 2 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 1 generation backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- This deviceK113451 Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software…Nidek Technologies Srl · 2012
- Descendant · cites it directly · 0 of its ownK202097 Fundus CameraHuvitz Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202097Fundus CameraHuvitz Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −2 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −1 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| 0 (this device) | K113451 | Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software NA Vis-EX | Nidek Technologies Srl | 2012 | — |
| +1 | K202097 | Fundus Camera | Huvitz Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000Summary page 2…TRADITIONAL 510(K) PREMARKET NOTIFICATION Section 05 510(k) Summary (Cont.) PREDICATE DEVICES Nidiek NM-1000 (K014274) Carl Zeiss Meditec FF450 with Fundus Camera and VISLIPAC System (K01 1977) Nidek Technologies Orion (K07023 ) INDICATIONS FOR U… | 2002 |
| * | K011877 | FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus… Our reading of the summary gave K011977, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Carl Zeiss Meditec FF450 with Fundus Camera and VISUPAC System”. | 2001 |
| Kept off the family tree | K070023 | FDA’s K070023 is Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
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 |
|---|---|---|---|
| K202097 | Fundus Camera | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 16, 2014 | Class II | Z-1980-2014 | Device Design | Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. |
| Aug 1, 2013 | Class II | Z-2046-2013 | Software design | Under certain circumstances, the Left eye image may be saved as the Right eye image. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K202097 (Huvitz Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K014274.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX is intended to capture, display, store and manipulate images of the retina and the anterior segment of the eye, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113451: Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software NA Vis-EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113451
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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