510(k) · Cleared
ClearedHeidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heidelberg Engineering · MXK Device, Analysis, Anterior Segment
Cleared on Oct 13, 2004 as substantially equivalent to K012416 (Nidek Technologies Srl, 2001) after a 9-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Oct 13, 2004
- Review
- 9 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912514 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK912514 Tandem Scanning MicroscopeTandem Scanning Corp. · 1991
- 2 generations backK971953 ConfoscanTomey Corporation USA · 1997
- 1 generation backK012416 Confoscan 2 Confocal MicroscopeNidek Technologies Srl · 2001
- This deviceK042742 Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)Heidelberg Engineering · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912514 | Tandem Scanning Microscope | Tandem Scanning Corp. | 1991 | — |
| −2 | K971953 | Confoscan | Tomey Corporation USA | 1997 | — |
| −1 | K012416 | Confoscan 2 Confocal Microscope | Nidek Technologies Srl | 2001 | — |
| 0 (this device) | K042742 | Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM) | Heidelberg Engineering | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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 MXK? 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 MXK device
- #1 K251848 Pentacam® Cornea OCTscore 13.7 · 10 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 |
|---|---|---|---|
| * | K012416 | Confoscan 2 Confocal MicroscopeSummary page 1…ope, a preamend- ment device, and to the "Nidek Confoscan 2" device, a Class II device that received 510(k) market clearance on October 26, 2001, document contxol number K012416. Device Description The system consists of the HRT 1I laser scanning camera, the Rostock Cornea Module optics, a mount with headr… | 2001 |
| * | — | slit-amp biomicroscope Named without a submission number |
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 13 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MXK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXK
Too few MXK 510(k)s in any year since 2007 to give a median.
Recalls per year · MXK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXK
1in 2025
MAUDE reports naming product code MXK, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Imaging and observation of the cellular layers of the anterior segment of the human eye, for the diagnosis and management of anterior segment diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042742: Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042742
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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