510(k) · Cleared
ClearedHeidelberg Engineering Slitlamp-Oct (SL-Oct)
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 Jan 13, 2006 as substantially equivalent to K030393 (Haag-Streit Holding AG, 2003) after an 86-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Jan 13, 2006
- Review
- 86 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K955442 (1996). 11 ancestors in all, the oldest K781994 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 3 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 2 generations backK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- 1 generation backK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- This deviceK052935 Heidelberg Engineering Slitlamp-Oct (SL-Oct)Heidelberg Engineering · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −3 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −2 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| −1 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| 0 (this device) | K052935 | Heidelberg Engineering Slitlamp-Oct (SL-Oct) | Heidelberg Engineering | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K030393 | Optical Low Coherence Reflectometry (Olcr) PachymeterSummary page 2…Pachymeter k number K030393 Indications for use Imaging and observation of the Biometric diagnose… | 2003 |
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 10 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K030393.
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?
The SL OCT is an add on for a slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used for diagnostic purposes.
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/K052935 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052935: Heidelberg Engineering Slitlamp-Oct (SL-Oct).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052935
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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