510(k) · Cleared
ClearedZeiss Cataract Suite Markerless
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Sep 9, 2014 as substantially equivalent to K101861 (Truevision Systems, Incorporated, 2010) after a 138-day review. Its family tree reaches back 7 generations to 1990. 8 later devices descend from it.
- Decided
- Sep 9, 2014
- Review
- 138 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896095 (1990). 16 ancestors in all, the oldest K870039 (1987). 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 3 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 2 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 1 generation backK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- This deviceK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- Descendant · cites it directly · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
- Descendant · cites it directly · 2 of its ownK180858 CALLISTO eyeCarl Zeiss Meditec, AG · 2018
- Descendant · 2 generations on · 1 of its ownK231676 CALLISTO eyeCarl Zeiss Meditec, AG · 2023
- Descendant · 3 generations on · 1 of its ownK173771 IOLMaster 700Carl Zeiss Meditec, AG · 2018 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · cites it directly4descendants
- K170171IOLMaster 700Carl Zeiss Meditec, AG · 2017 · 2 generations on3descendants
- K180858CALLISTO eyeCarl Zeiss Meditec, AG · 2018 · cites it directly2descendants
- K231676CALLISTO eyeCarl Zeiss Meditec, AG · 2023 · 2 generations on1descendant
- K173771IOLMaster 700Carl Zeiss Meditec, AG · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −3 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −2 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −1 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| 0 (this device) | K141068 | Zeiss Cataract Suite Markerless | Carl Zeiss Meditec, AG | 2014 | — |
| +1 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| +2 | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | 1 |
| +1 | K180858 | CALLISTO eye | Carl Zeiss Meditec, AG | 2018 | — |
| +2 | K231676 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023 | — |
| +3 | K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 HJO? 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 HJO device
- #1 K253834 Visuref 600score 13.1 · 8 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 |
|---|---|---|---|
| * | K101861 | Truevision 3D Visualization and Guidance SystemSummary page 5…ZEISS Cataract Suite markerless is similar in function and application in cataract surgery to the predicate device, the TrueVision 3D Visualization and Guidance System (K101861). The visualization system displays real-time images during ophthalmic surgery on a flat-panel digital display device positioned… | 2010 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K143275 (Carl Zeiss Meditec, Inc., 2015) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K101861.
How does its category compare?
All HJO devicesHJO Biomicroscope, Slit-Lamp, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HJO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HJO
232in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HJO
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HJO
20in 2025
MAUDE reports naming product code HJO, 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 | 1 |
| 2008 | 4 | 117 | 0 | 3 |
| 2009 | 3 | 91 | 0 | 3 |
| 2010 | 5 | 121 | 0 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 2 | — | 2 | 16 |
| 2014 | 10 | 196 | 0 | 4 |
| 2015 | 2 | — | 2 | 8 |
| 2016 | 5 | 243 | 0 | 15 |
| 2017 | 9 | 232 | 0 | 15 |
| 2018 | 2 | — | 1 | 11 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ZEISS Cataract Suite markerless workflow uses a preoperative image capture tool from the IOLMaster 500 that permits visualization and guidance during cataract surgery using CALLISTO eye. The ZEISS Cataract Suite markerless utilizes an ophthalmic surgical microscope and the following medical devices: IOLMaster 500 The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius…
Read the full statement (225 words)
The ZEISS Cataract Suite markerless workflow uses a preoperative image capture tool from the IOLMaster 500 that permits visualization and guidance during cataract surgery using CALLISTO eye. The ZEISS Cataract Suite markerless utilizes an ophthalmic surgical microscope and the following medical devices:
IOLMaster 500
The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.
This device is intended for use by physicians and eye-care professionals and may only be used under supervision of a physician.
CALLISTO eye
CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope.
The graphical guidance tools, as displayed on the CALLISTO eye Panel PC or microscope eye piece, aid the surgeon to insert, align, position, and register an artificial lens. These tools are intended for anterior segment ophthalmic surgical procedures, including positioning and angular alignment of toric intraocular lenses, limbal relaxing incisions and capsulorhexis.
The system utilizes surgeon information for position of graphical guidance tools.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141068: Zeiss Cataract Suite Markerless.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141068
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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