510(k) · Cleared
Cleared3nethra neo HD FA; 3nethra neo HD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Forus Health Pvt.Ltd · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Aug 14, 2025 as substantially equivalent to K183059 (Forus Health Pvt.Ltd, 2018) after a 266-day review. Its family tree reaches back 6 generations to 2008.
- Decided
- Aug 14, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K081858 (2008). No later device cites it as a predicate yet.
- Root · 6 generations backK081858 Retcam 3 Ophthalmic Imaging SystemClarity Medical Systems · 2008 · Recalled
- 5 generations backK083771 Retcam Portable Ophthalmic Imaging System, Model RCPClarity Medical Systems · 2009
- 4 generations backK090326 Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic…Clarity Medical Systems · 2009 · Recalled
- 3 generations backK102859 Retcam 3 Opthalmic Imaging SystemClarity Medical Systems · 2011 · Recalled
- 2 generations backK170527 Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical · 2017
- 1 generation backK183059 3nethra neoForus Health Pvt.Ltd · 2018
- This deviceK243600 3nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K081858 | Retcam 3 Ophthalmic Imaging System | Clarity Medical Systems | 2008 | 3 |
| −5 | K083771 | Retcam Portable Ophthalmic Imaging System, Model RCP | Clarity Medical Systems | 2009 | — |
| −4 | K090326 | Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems | Clarity Medical Systems | 2009 | 2 |
| −3 | K102859 | Retcam 3 Opthalmic Imaging System | Clarity Medical Systems | 2011 | 2 |
| −2 | K170527 | Phoenix Clinical ICON | Phoenix Technology Group, Inc. Dba Phoenix Clinical | 2017 | — |
| −1 | K183059 | 3nethra neo | Forus Health Pvt.Ltd | 2018 | — |
| 0 (this device) | K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | 2025 | — |
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.
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 17 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
3nethra neo HD FA is used as a wide-field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants. The device acquires only images and does not provide any pathological analysis or diagnosis for treatment.
3nethra neo HD is used as a wide-field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants. The device acquires only images and does not provide any pathological analysis or diagnosis for treatment.
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/K243600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243600: 3nethra neo HD FA; 3nethra neo HD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243600
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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