510(k) · Cleared
ClearedOrbscan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technolas Perfect Vision GmbH · MXK Device, Analysis, Anterior Segment
Cleared on Mar 5, 1999 as substantially equivalent to K940647 (Orbtek, Inc., 1994) after an 81-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Mar 5, 1999
- Review
- 81 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940647 (1994). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K040913Ngdi (Next Generation Diagnostic Instrument)Bausch & Lomb · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940647 | Orbscan (TM) Keratometer | Orbtek, Inc. | 1994 | — |
| 0 (this device) | K984443 | Orbscan | Technolas Perfect Vision GmbH | 1999 | — |
| +1 | K040913 | Ngdi (Next Generation Diagnostic Instrument) | Bausch & Lomb | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K940647 | Orbscan (TM) KeratometerSummary page 1…edicate Device The predicate device is the original Orbscan manufactured by Orbtek, Inc,, and cleared for marketing by FDA on 07/06/94 with premarket notification number K940647. Tntended Use The Orbscan 1l Keratometer is intended to scan, map and display the geometry of the anterior segment of the eyc.… | 1994 |
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 |
|---|---|---|---|
| K040913 | Ngdi (Next Generation Diagnostic Instrument) | 2004 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K040913 (Bausch & Lomb, 2004) has gone furthest, with 0 descendants of its own.
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 Orbscan II intended use is for scanning,
mapping and displaying the geometry of the anterior
segment of the eye.
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/K984443 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984443: Orbscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984443
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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