510(k) · Cleared
ClearedNFC-700 non-mydriatic auto fundus camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crystalvue Medical Corporation · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jan 2, 2019 as substantially equivalent to K122572 (Optovue, Inc., 2013) after a 141-day review. Its family tree reaches back 8 generations to 1995. 3 later devices descend from it.
- Decided
- Jan 2, 2019
- Review
- 141 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K941234 (1995). 20 ancestors in all, the oldest K810880 (1981). 3 later devices descend from it, 3 citing it directly.
- 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 deviceK182199 NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019
- Descendant · cites it directly · 0 of its ownK242508 Verily Numetric Retinal CameraVerily Life Sciences, LLC · 2024
- Descendant · cites it directly · 0 of its ownK230627 Zilia Ocular FC (ZIL-10002)Zilia, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK210197 NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation · 2021
Most influential descendants
Showing 3 of 3 · See all- K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC · 2024 · cites it directly0descendants
- K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc. · 2023 · cites it directly0descendants
- K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation · 2021 · cites it directly0descendants
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) | K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | 2019 | — |
| +1 | K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | 2024 | — |
| +1 | K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | 2023 | — |
| +1 | K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | 2021 | — |
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 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K122572 | Icam Fundus CameraSummary page 4…21 CFR § 886.1120 Predicate Devices Trade Name: Optovue iCam Fundus Camera Classification Name: HKI, Ophthalmic Camera, AC power 510(k) Number: K122572 Intended Use NFC-700 provides non-mydriatic, color posterior chamber and external images of the eye as an aid to clin… | 2013 |
What descends from it? (3)
3 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 24 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K242508 (Verily Life Sciences, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K122572.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
NFC-700 is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions.
NFC-700 is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182199: NFC-700 non-mydriatic auto fundus camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182199
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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