510(k) · Cleared
ClearedClearpath DS-120(R) Lens Fluorescence Biomicroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Freedom Meditech, Inc. · MYC Ophthalmoscope, Laser, Scanning
Cleared on Jan 31, 2013 as substantially equivalent to K102492 (Optos Plc., 2010) after a 489-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Jan 31, 2013
- Review
- 489 days
- Class
- Class II
- Product code
- MYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K871268 (1987). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK871268 Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 1987
- 4 generations backK983999 PANORAMIC200 OpthalmoscopeOptos Plc. · 1999
- 3 generations backK042001 Panoramic 200AOptos Plc. · 2004
- 2 generations backK060424 Panoramic, Model 200MAOptos Plc. · 2006
- 1 generation backK102492 P200MAAFOptos Plc. · 2010
- This deviceK112880 Clearpath DS-120(R) Lens Fluorescence BiomicroscopeFreedom Meditech, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871268 | Rodenstock Scanning Laser Ophthalmoscope | G. Rodenstock Instrumente GmbH | 1987 | — |
| −4 | K983999 | PANORAMIC200 Opthalmoscope | Optos Plc. | 1999 | — |
| −3 | K042001 | Panoramic 200A | Optos Plc. | 2004 | — |
| −2 | K060424 | Panoramic, Model 200MA | Optos Plc. | 2006 | — |
| −1 | K102492 | P200MAAF | Optos Plc. | 2010 | — |
| 0 (this device) | K112880 | Clearpath DS-120(R) Lens Fluorescence Biomicroscope | Freedom Meditech, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2010 | 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 MYC? 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 MYC device
- #1 K261255 Kowa FM-600score 12.3 · 2 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 |
|---|---|---|---|
| * | K102492 | P200MAAFSummary page 1…Ophthalmoscope (Class 11) DEVICE CLASSIFICATION: 21 CFR 886.1570 PRODUCT CODE: MYC PREDICATE DEVICE: Optos PIC P200MAAF Ophthalmoscope, K1 02492 1.3 SUBSTANTIALLY EQUIVALENT To 510(K) NUMBER TRADE OR PROPRIETARY OR MNFCUE… | 2010 |
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 26 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K102492.
How does its category compare?
All MYC devicesMYC Ophthalmoscope, Laser, Scanning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MYC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYC
116in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYC
No recall names MYC since 2007.
Adverse event reports per year · MYC
2in 2023
MAUDE reports naming product code MYC, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 116 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ClearPath DS-1200 Lens Fluorescence Biomicroscope is indicated for use to detect autofluorescence of the crystalline lens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112880: Clearpath DS-120(R) Lens Fluorescence Biomicroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112880
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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