510(k) · Cleared
Recalled · Class II · 2015Iolmaster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss, Inc. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Mar 20, 2000 as substantially equivalent to K961171 (Carl Zeiss, Inc., 1996) and 3 other predicates after a 166-day review. Its family tree reaches back 1 generation to 1979. 17 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 20, 2000
- Review
- 166 days
- Class
- Class II
- Product code
- HJO
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 1 generation to K781994 (1979). 4 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK781994 Autokeratometer, InstrumentZeiss Humphrey System · 1979
- This deviceK993357 IolmasterCarl Zeiss, Inc. · 2000
- Descendant · cites it directly · 16 of its ownK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- Descendant · cites it directly · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- Descendant · cites it directly · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- Descendant · 2 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
- Descendant · 2 generations on · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K030393Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003 · cites it directly16descendants
- K082891Lenstar, Model LS900Haag-Streit AG · 2009 · cites it directly14descendants
- K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · cites it directly10descendants
- K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 2 generations on9descendants
- K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781994 | Autokeratometer, Instrument | Zeiss Humphrey System | 1979 | — |
| 0 (this device) | K993357 | Iolmaster | Carl Zeiss, Inc. | 2000 | — |
| +1 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| +1 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| +1 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| +2 | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | 4 |
| +2 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K961171 | Humphrey Oct ScannerSummary page 1…cation Name Keratoscope: § 886.1350 ' AC-Powered slitlamp biomicroscope: 886.1850 We are claiming substantial equivalence to the technology of the Humphrey Systems OCT (K961171) and the technology and indications of the Zeiss SL 120 slit lamp (K925641) and the indications of the Quantel Medical B-Scan ‘S’… | 1996 |
| * | K925641 | Zeiss 20 SL Slit-Lamp & Mechanical MicromanipulatrSummary page 1…6.1850 We are claiming substantial equivalence to the technology of the Humphrey Systems OCT (K961171) and the technology and indications of the Zeiss SL 120 slit lamp (K925641) and the indications of the Quantel Medical B-Scan ‘S’ Model (K926251), for determining axial eye length measurement and anterior… | 1993 |
| * | K926251 | B-Scan Opthalmic Ultrasound Imaging SystemSummary page 1…he Humphrey Systems OCT (K961171) and the technology and indications of the Zeiss SL 120 slit lamp (K925641) and the indications of the Quantel Medical B-Scan ‘S’ Model (K926251), for determining axial eye length measurement and anterior chamber depth measurement, and the Humphrey Auto Keratometer Model 42… | 1993 |
| * | K781994 | Autokeratometer, InstrumentSummary page 1…tel Medical B-Scan ‘S’ Model (K926251), for determining axial eye length measurement and anterior chamber depth measurement, and the Humphrey Auto Keratometer Model 420 (K781994) for corneal radius measurement, which already have pre-market clearance for the indications of providing measurements and genera… | 1979 |
What descends from it? (17)
See all 173 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?
- None of the 4 ancestors has a recall.
- Of its descendants, K030393 (Haag-Streit Holding AG, 2003) has gone furthest, with 16 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.
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?
This device will be used in the same manner as all ophthalmic diagnostic devices used to obtain ocular measurements (for axial length, anterior chamber depth and corneal radius), and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993357 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993357: Iolmaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993357
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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