510(k) · Cleared
ClearedRetCam Envision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Apr 13, 2021 as substantially equivalent to K182263 (Natus Medical Incorporated, 2018) after a 134-day review. Its family tree reaches back 4 generations to 2008.
- Decided
- Apr 13, 2021
- Review
- 134 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K081858 (2008). No later device cites it as a predicate yet.
- 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 backK182263 RetCam 3 ; RetCam Shuttle ; RetCam PortableNatus Medical Incorporated · 2018
- This deviceK203500 RetCam EnvisionNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2021
View 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 | K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | Natus Medical Incorporated | 2018 | — |
| 0 (this device) | K203500 | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2021 | — |
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? (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 |
|---|---|---|---|
| * | K182263 | RetCam 3 ; RetCam Shuttle ; RetCam PortableSummary page 4…r: 21CFR 886.1120 Classification Name: Ophthalmic camera. Product code: HKI Device Class: 11 Predicate Device: RetCam 3; RetCam Shuttle; RetCam Portable (K182263) Natus Medical incorporated I natus.com PAGE 1 of 10 510(K): K203500 RE… | 2018 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 4 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. 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?
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 1 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 1 or 2, with plus disease) * in 35-37 week postmenstrual infants.
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/K203500 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203500: RetCam Envision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203500
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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