510(k) · Cleared
ClearedPhoenix Clinical ICON
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phoenix Technology Group, Inc. Dba Phoenix Clinical · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Sep 15, 2017 as substantially equivalent to K102859 (Clarity Medical Systems, 2011) after a 205-day review. Its family tree reaches back 4 generations to 2008. 3 later devices descend from it.
- Decided
- Sep 15, 2017
- Review
- 205 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K081858 (2008). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK081858 Retcam 3 Ophthalmic Imaging SystemClarity Medical Systems · 2008 · Recalled
- 3 generations backK083771 Retcam Portable Ophthalmic Imaging System, Model RCPClarity Medical Systems · 2009
- 2 generations backK090326 Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic…Clarity Medical Systems · 2009 · Recalled
- 1 generation backK102859 Retcam 3 Opthalmic Imaging SystemClarity Medical Systems · 2011 · Recalled
- This deviceK170527 Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical · 2017
- Descendant · cites it directly · 1 of its ownK183059 3nethra neoForus Health Pvt.Ltd · 2018
- Descendant · 2 generations on · 0 of its ownK243600 3nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd · 2025
- Descendant · cites it directly · 0 of its ownK223575 Phoenix ICON, Phoenix ICON GONeolight, LLC · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K081858 | Retcam 3 Ophthalmic Imaging System | Clarity Medical Systems | 2008 | 3 |
| −3 | K083771 | Retcam Portable Ophthalmic Imaging System, Model RCP | Clarity Medical Systems | 2009 | — |
| −2 | K090326 | Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems | Clarity Medical Systems | 2009 | 2 |
| −1 | K102859 | Retcam 3 Opthalmic Imaging System | Clarity Medical Systems | 2011 | 2 |
| 0 (this device) | K170527 | Phoenix Clinical ICON | Phoenix Technology Group, Inc. Dba Phoenix Clinical | 2017 | — |
| +1 | K183059 | 3nethra neo | Forus Health Pvt.Ltd | 2018 | — |
| +2 | K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | 2025 | — |
| +1 | K223575 | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K102859 | Retcam 3 Opthalmic Imaging SystemSummary page 4…886.1120 Product Code: HKI Classification Panel: Ophthalmic Predicate Device(s): RetCam 3 K102859 Device Description: The Phoenix Clinical ICON is a battery and AC-powered, cart-based, non-sterile, wide-field, handheld, high… | 2011 |
What descends from it? (3)
2 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 9 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K183059 (Forus Health Pvt.Ltd, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K102859.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
General ophthalmic imaging including retinal, corneal, and external structures of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170527: Phoenix Clinical ICON.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170527
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