510(k) · Cleared
Recalled · Class II · 2014Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarity Medical Systems · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Nov 25, 2009 as substantially equivalent to K081858 (Clarity Medical Systems, 2008) and 1 other predicate after a 289-day review. Its family tree reaches back 2 generations to 2008. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 25, 2009
- Review
- 289 days
- Class
- Class II
- Product code
- HKI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K081858 (2008). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK081858 Retcam 3 Ophthalmic Imaging SystemClarity Medical Systems · 2008 · Recalled
- 1 generation backK083771 Retcam Portable Ophthalmic Imaging System, Model RCPClarity Medical Systems · 2009
- This deviceK090326 Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic…Clarity Medical Systems · 2009
- Descendant · cites it directly · 4 of its ownK102859 Retcam 3 Opthalmic Imaging SystemClarity Medical Systems · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK170527 Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical · 2017
- Descendant · 2 generations on · 1 of its ownK183059 3nethra neoForus Health Pvt.Ltd · 2018
- Descendant · cites it directly · 1 of its ownK182263 RetCam 3 ; RetCam Shuttle ; RetCam PortableNatus Medical Incorporated · 2018
- Descendant · 3 generations on · 0 of its ownK243600 3nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K102859Retcam 3 Opthalmic Imaging SystemClarity Medical Systems · 2011 · cites it directly4descendants
- K170527Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical · 2017 · 2 generations on3descendants
- K1830593nethra neoForus Health Pvt.Ltd · 2018 · 2 generations on1descendant
- K182263RetCam 3 ; RetCam Shuttle ; RetCam PortableNatus Medical Incorporated · 2018 · cites it directly1descendant
- K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K081858 | Retcam 3 Ophthalmic Imaging System | Clarity Medical Systems | 2008 | 3 |
| −1 | K083771 | Retcam Portable Ophthalmic Imaging System, Model RCP | Clarity Medical Systems | 2009 | — |
| 0 (this device) | K090326 | Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems | Clarity Medical Systems | 2009 | — |
| +1 | K102859 | Retcam 3 Opthalmic Imaging System | Clarity Medical Systems | 2011 | 2 |
| +2 | K170527 | Phoenix Clinical ICON | Phoenix Technology Group, Inc. Dba Phoenix Clinical | 2017 | — |
| +2 | K183059 | 3nethra neo | Forus Health Pvt.Ltd | 2018 | — |
| +1 | K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | Natus Medical Incorporated | 2018 | — |
| +3 | K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 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 12.8 · 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? (2)
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 |
|---|---|---|---|
| * | K081858 | Retcam 3 Ophthalmic Imaging SystemSummary page 1…lass: Class II Classification Panel: Ophthalmology Product Code(s): HK[ Equivalent Predicate RetCam II Ophthalmic Imaging System, K08 1858 Devices: RetCarm 3)Ophthalmic Imaging System, K081858 RetCam Shuttle Ophthal… | 2008 |
| * | K083771 | Retcam Portable Ophthalmic Imaging System, Model RCPSummary page 1…stem, K081858 RetCam Shuttle Ophthalmic Imaging System, K081858 RetCamn Portable Ophthalmic Imaging System, K083771 Device Description: RetCarn Ophthalmic Imaging Systems utilize a digital camera in a handpiece with multiple fi… | 2009 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2014 | Class II | Z-1154-2014 | Software Manufacturing/Software Deployment | Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly. |
| Feb 2, 2012 | Not classified | Z-1099-2012 | Software design | Still images extracted from video recordings may be mislabeled as to right and left eye. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 10 months on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K102859 (Clarity Medical Systems, 2011) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K081858.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Each and all above listed RetCam Systems are indicated for: * General ophthalmic imaging including retinal, corneal, and external imaging; * Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP). * Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type I ROP (zone 1, any…
Read the full statement (118 words)
Each and all above listed RetCam Systems are indicated for:
* General ophthalmic imaging including retinal, corneal, and external imaging;
* Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP).
* Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type I ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone I or 2, with plus disease)* in 35-37 week postmenstrual infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090326 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090326: Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090326
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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