510(k) · Cleared
ClearedUnity DX (Udx)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cylite Pty., Ltd. · OBO Tomography, Optical Coherence
Cleared on Dec 23, 2025 as substantially equivalent to K231760 (Cylite Pty., Ltd., 2024) and 1 other predicate after a 125-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Dec 23, 2025
- Review
- 125 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K896095 (1990). 68 ancestors in all, the oldest K781994 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations between
- 3 generations backK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- 2 generations backK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
- 1 generation backK173771 IOLMaster 700Carl Zeiss Meditec, AG · 2018 · Recalled
- This deviceK252633 Unity DX (Udx)Cylite Pty., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 10 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 9 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 8 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 7 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 6 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 5 generations backK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- 4 generations backK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- 3 generations backK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- 2 generations backK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
- 1 generation backK173771 IOLMaster 700Carl Zeiss Meditec, AG · 2018 · Recalled
- This deviceK252633 Unity DX (Udx)Cylite Pty., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −10 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −9 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −8 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −7 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −6 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −5 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| −4 | K141068 | Zeiss Cataract Suite Markerless | Carl Zeiss Meditec, AG | 2014 | — |
| −3 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| −2 | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | 1 |
| −1 | K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018 | 1 |
| 0 (this device) | K252633 | Unity DX (Udx) | Cylite Pty., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 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 OBO? 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 OBO device
- #1 K250868 SPECTRALIS HRA+OCT and variantsscore 16.2 · 14 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 |
|---|---|---|---|
| * | K231760 | HP-Oct (HP-Oct)Summary page 6…ERENCE DEVICE [per 807.92(a)(3)] Predicate Device 1: Company Name: Cylite Pty. Ltd. Device Trade Name: HP-OCT™ (K231760) Regulation Number: 21 CFR 886.1570 Regulation Description: Ophthalmoscope Device C… | 2024 |
| * | K173771 | IOLMaster 700Summary page 6…duct Code: OBO Subsequent Product Codes: MXK, HJO Predicate Device 2 Company Name Carl Zeiss Meditec AG (K173771) Device Trade Name: IOL Master 700 Regulation Number: 21 CFR 886.1850 Regulati… | 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 35 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 13 of the 68 ancestors have a recall of any class.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OBO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBO
125in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBO
4in 2025
MAUDE reports naming product code OBO, 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 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 4 | 151 | 0 | 0 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 2 | — | 2 | 0 |
| 2012 | 3 | 269 | 2 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 152 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 4 | 125 | 0 | 1 |
| 2017 | 4 | 118 | 0 | 0 |
| 2018 | 6 | 87 | 1 | 1 |
| 2019 | 5 | 249 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 1 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 7 | 262 | 0 | 3 |
| 2024 | 8 | 157 | 0 | 3 |
| 2025 | 3 | 125 | 0 | 4 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Unity DX instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for
visualization of anterior and posterior ocular structures and measurement of anterior segment and biometric
parameters including:
*Axial Length
* Anterior Chamber Depth
* Central Corneal Thickness
* Lens Thickness
The Reference Image functionality is intended for use as an ocular image capture tool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252633: Unity DX (Udx).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252633
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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