510(k) · Cleared
Recalled · Class II · 2015Iolmaster 500
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 Apr 12, 2013 as substantially equivalent to K101182 (Carl Zeiss Meditec, AG, 2010) after a 247-day review. Its family tree reaches back 6 generations to 1996. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 12, 2013
- Review
- 247 days
- Class
- Class II
- Product code
- HJO
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 6 generations to K955442 (1996). 20 ancestors in all, the oldest K781994 (1979). 9 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 5 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 4 generations backK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- 3 generations backK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- 2 generations backK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- 1 generation backK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- This deviceK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013
- 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 · 3 of its ownK152311 Pentacam AXLOculus Optikgerate GmbH · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK173771 IOLMaster 700Carl Zeiss Meditec, AG · 2018 · Recalled
- Descendant · 4 generations on · 0 of its ownK252633 Unity DX (Udx)Cylite Pty., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · cites it directly4descendants
- K170171IOLMaster 700Carl Zeiss Meditec, AG · 2017 · 2 generations on3descendants
- K152311Pentacam AXLOculus Optikgerate GmbH · 2016 · cites it directly3descendants
- K173771IOLMaster 700Carl Zeiss Meditec, AG · 2018 · 3 generations on1descendant
- K252633Unity DX (Udx)Cylite Pty., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −5 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −4 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| −3 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| −2 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| −1 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| 0 (this device) | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | — |
| +1 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| +2 | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | 1 |
| +1 | K152311 | Pentacam AXL | Oculus Optikgerate GmbH | 2016 | 3 |
| +3 | K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018 | 1 |
| +4 | 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 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K101182 | Iolmaster 500Summary page 2…lOLMaster 500, the subject of this 510(k), is substantially equivalent to the predicate lOLMaster 500 (Carl Zeiss Meditec, AG) cleared for marketing under 510(k) number K101 182 in October 20 10. DEVICE DESCRIPTION The lOLMaster 500 is a non-contact biometry instrument for measurements of the eye require… | 2010 |
What descends from it? (9)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 27, 2015 | Class II | Z-0357-2016 | Software design | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. |
| Oct 27, 2015 | Class II | Z-0358-2016 | Software design | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. |
| Oct 23, 2013 | Class II | Z-0333-2014 | Software in the Use Environment | The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could… |
| Oct 23, 2013 | Class II | Z-0334-2014 | Software in the Use Environment | The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K143275 (Carl Zeiss Meditec, Inc., 2015) has gone furthest, with 4 descendants of its own.
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. 2013, 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 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 the supervision of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122418: Iolmaster 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122418
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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