510(k) · Cleared
ClearedRHA2020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Annidis Health Systems Corp. · HLI Ophthalmoscope, Ac-Powered
Cleared on Jul 8, 2011 as substantially equivalent to K983999 (Optos Plc., 1999) and 2 other predicates after a 36-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Jul 8, 2011
- Review
- 36 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K871268 (1987). 9 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871268 | Rodenstock Scanning Laser Ophthalmoscope | G. Rodenstock Instrumente GmbH | 1987 | — |
| −1 | K983999 | PANORAMIC200 Opthalmoscope | Optos Plc. | 1999 | — |
| 0 (this device) | K111531 | RHA2020 | Annidis Health Systems Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 2 | 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 HLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K983999 | PANORAMIC200 OpthalmoscopeSummary page 1…ivalent to a combination of the following predicate devices: 510(k) No. Trade Name Product Code(s) K983999 Panoramic 200 Ophthalmoscope HLI K072259 Ophthalmoscope F-10… | 1999 |
| * | K072259 | Ophthalmoscope F-10Summary page 1…k) No. Trade Name Product Code(s) K983999 Panoramic 200 Ophthalmoscope HLI K072259 Ophthalmoscope F-10 MYC K(092056 Smartscope M3-1 FYI… | 2008 |
| * | K092056 | Optomed Smartscope, Model M3-1 EY1Summary page 3…green, and red and affords Indocyanine green (ICG) and fluorescein (FAG) angiography. * The Optomed Smartscope M3-1 EYI1 (K092056) is a hand-held digital ophthalmoscope used to capture digital images and video of the cornea, aqueous,… | 2009 |
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 24 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K983999.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HLI
112in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HLI
2in 2024
MAUDE reports naming product code HLI, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 36 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 4 | 112 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 2 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111531: RHA2020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111531
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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