510(k) · Cleared
Recalled · Class II · 2020IOLMaster 700
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 Aug 24, 2018 as substantially equivalent to K170171 (Carl Zeiss Meditec, AG, 2017) after a 256-day review. Its family tree reaches back 10 generations to 1990. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 24, 2018
- Review
- 256 days
- Class
- Class II
- Product code
- HJO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K896095 (1990). 40 ancestors in all, the oldest K781994 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- 2 generations backK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- 1 generation backK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
- This deviceK173771 IOLMaster 700Carl Zeiss Meditec, AG · 2018
- Descendant · cites it directly · 0 of its ownK252633 Unity DX (Udx)Cylite Pty., Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 6 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 5 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 4 generations backK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- 3 generations backK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- 2 generations backK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- 1 generation backK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
- This deviceK173771 IOLMaster 700Carl Zeiss Meditec, AG · 2018
Most influential descendants
Showing 1 of 1 · See all- K252633Unity DX (Udx)Cylite Pty., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −6 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −5 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −4 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| −3 | K141068 | Zeiss Cataract Suite Markerless | Carl Zeiss Meditec, AG | 2014 | — |
| −2 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| −1 | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | 1 |
| 0 (this device) | K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018 | — |
| +1 | 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 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K170171 | IOLMaster 700Summary page 4…Class II Product Code: HJO 3. PREDICATE DEVICE: The predicate device is the previous version of the IOLMaster 700, cleared under K170171. 4. DEVICE DESCRIPTION: The IOLMaster 700 is a non-invasive optical biometry instrument for visualization and measureme… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252633 | Unity DX (Udx) | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2020 | Class II | Z-1133-2021 | Software design | When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 40 ancestors have a recall of any class.
- Of its descendants, K252633 (Cylite Pty., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K170171.
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. 2018, 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 IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures:
• Lens thickness
• Corneal curvature and thickness
• Axial length
• Anterior chamber depth
• Pupil diameter
• White-to-white distance (WTW)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173771: IOLMaster 700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173771
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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