510(k) · Cleared
ClearedPanoramic 200A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optos Plc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Oct 7, 2004 as substantially equivalent to K983999 (Optos Plc., 1999) and 3 other predicates after a 73-day review. Its family tree reaches back 2 generations to 1987. 9 later devices descend from it.
- Decided
- Oct 7, 2004
- Review
- 73 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K871268 (1987). 5 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK871268 Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 1987
- 1 generation backK983999 PANORAMIC200 OpthalmoscopeOptos Plc. · 1999
- This deviceK042001 Panoramic 200AOptos Plc. · 2004
- Descendant · cites it directly · 8 of its ownK060424 Panoramic, Model 200MAOptos Plc. · 2006
- Descendant · 2 generations on · 7 of its ownK102492 P200MAAFOptos Plc. · 2010
- Descendant · 3 generations on · 5 of its ownK142897 P200DTxOptos Plc. · 2015
- Descendant · 4 generations on · 3 of its ownK173707 P200TEOptos Plc. · 2018
- Descendant · 5 generations on · 1 of its ownK231673 P200TE (A10700)Optos Plc. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K060424Panoramic, Model 200MAOptos Plc. · 2006 · cites it directly8descendants
- K102492P200MAAFOptos Plc. · 2010 · 2 generations on7descendants
- K142897P200DTxOptos Plc. · 2015 · 3 generations on5descendants
- K173707P200TEOptos Plc. · 2018 · 4 generations on3descendants
- K231673P200TE (A10700)Optos Plc. · 2023 · 5 generations on1descendant
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) | K042001 | Panoramic 200A | Optos Plc. | 2004 | — |
| +1 | K060424 | Panoramic, Model 200MA | Optos Plc. | 2006 | — |
| +2 | K102492 | P200MAAF | Optos Plc. | 2010 | — |
| +3 | K142897 | P200DTx | Optos Plc. | 2015 | — |
| +4 | K173707 | P200TE | Optos Plc. | 2018 | — |
| +5 | K231673 | P200TE (A10700) | Optos Plc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (4)
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…redicate Devices Trade Name Manufacturer 5 10(k) Panoramic 200 Optos K983999 Heidelberg Retina Angiography 2 Heidelberg Engineering K971671 Scanning Laser Ophthalmoscope(SLO) Roden… | 1999 |
| * | K971671 | Heidelberg Retina Angiograph FA/Icga (Hra/C)Summary page 1…5 10(k) Panoramic 200 Optos K983999 Heidelberg Retina Angiography 2 Heidelberg Engineering K971671 Scanning Laser Ophthalmoscope(SLO) Rodenstock K882517 Scanning Laser Ophthalmoscope(SLO) Rode… | 1997 |
| * | K882517 | Rodenstock Scanning Laser OphthalmoscopeSummary page 1…K983999 Heidelberg Retina Angiography 2 Heidelberg Engineering K971671 Scanning Laser Ophthalmoscope(SLO) Rodenstock K882517 Scanning Laser Ophthalmoscope(SLO) Rodenstock K871268 Intended Uses Optos plc's ("Optos") Panoramic… | 1989 |
| * | K871268 | Rodenstock Scanning Laser OphthalmoscopeSummary page 1…K971671 Scanning Laser Ophthalmoscope(SLO) Rodenstock K882517 Scanning Laser Ophthalmoscope(SLO) Rodenstock K871268 Intended Uses Optos plc's ("Optos") Panoramic 200A, Panoramic 200, Heidelberg Retina Angiography 2 and G.Rodenstock Instrumen… | 1987 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060424 | Panoramic, Model 200MA | 2006 | 8 |
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 2 companies; a new generation was cleared every 11.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K060424 (Optos Plc., 2006) has gone furthest, with 8 descendants of its own.
- 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.
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?
This device is indicated for use as a wide field and retinal fluorescence imaging ophithalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest themselves in the retina.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042001: Panoramic 200A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042001
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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