510(k) · Cleared
ClearedNFC-600 Automated Portable Retinal 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 Apr 13, 2021 as substantially equivalent to K182199 (Crystalvue Medical Corporation, 2019) after a 78-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Apr 13, 2021
- Review
- 78 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K941234 (1995). 21 ancestors in all, the oldest K810880 (1981). No later device cites it as a predicate yet.
- Root · 9 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 5 generations between
- 3 generations backK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- 2 generations backK122572 Icam Fundus CameraOptovue, Inc. · 2013
- 1 generation backK182199 NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019
- This deviceK210197 NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation · 2021
Show all 9 generations
- Root · 9 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 8 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 7 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 6 generations backK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
- 5 generations backK061768 MP-1 MicroperimeterNidek Technologies Srl · 2006
- 4 generations backK070231 ORIONNidek Technologies Srl · 2007
- 3 generations backK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- 2 generations backK122572 Icam Fundus CameraOptovue, Inc. · 2013
- 1 generation backK182199 NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019
- This deviceK210197 NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −8 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −7 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −6 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
| −5 | K061768 | MP-1 Microperimeter | Nidek Technologies Srl | 2006 | — |
| −4 | K070231 | ORION | Nidek Technologies Srl | 2007 | — |
| −3 | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| −2 | K122572 | Icam Fundus Camera | Optovue, Inc. | 2013 | — |
| −1 | K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K182199 | NFC-700 non-mydriatic auto fundus cameraSummary page 7…ison of Technological Characteristics with the Predicate Device Product Subject Device NFC-600 Predicate Device (K182199) Comparison Item NFC-600 provides non-mydriatic NFC-700 provides non-mydriatic… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 21 ancestors has a recall of any class.
- 2 other devices also cite its predicate K182199.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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-600 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-600 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 as stated in the FDA summary.
https://510kreport.com/device/K210197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210197: NFC-600 Automated Portable Retinal Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210197
Report an extraction error
Are you the manufacturer?
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