510(k) · Cleared
ClearedNgdi (Next Generation Diagnostic Instrument)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb · MXK Device, Analysis, Anterior Segment
Cleared on Jul 23, 2004 as substantially equivalent to K984443 (Technolas Perfect Vision GmbH, 1999) and 1 other predicate after a 106-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jul 23, 2004
- Review
- 106 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K955442 (1996). 7 ancestors in all, the oldest K930518 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 2 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 1 generation backK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- This deviceK040913 Ngdi (Next Generation Diagnostic Instrument)Bausch & Lomb · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −2 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −1 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| 0 (this device) | K040913 | Ngdi (Next Generation Diagnostic Instrument) | Bausch & Lomb | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984443 | OrbscanSummary page 1…s to which substantial equivalence is being claimed: Company: Ortek, Inc Device: Orbscan II 510(k) K984443 Date Cleared: March 5, 1999 Company: Bausch & Lomb, Incorporated Device:… | 1999 |
| Kept off the family tree | K010992 | Zywave Wavefront Diagnostic System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…December 19, 2003 Next Generation Diagnostic Instrument Premarket Notification 510(k) K010992 Date Cleared: Class I, Exempt Company: Bausch & Lomb, Incorporated Device:… | |
| * | K012873 | Documenting Laser Slit Lamp, DP 2010Summary page 2…Class I, Exempt Company: Bausch & Lomb, Incorporated Device: Documenting Laser Slit Lamp 510(k): K012873 Date Cleared: November 19, 2001 4. A description of the device that is the subject of the 510(k), including… | 2001 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 7 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?
Indicated Use is for scanning, mapping, and displaying the geometry of the anterior segment of the eye.
Also indicated for the measurement and analysis of optical aberrations of the eye by use of wavefront technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040913 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040913: Ngdi (Next Generation Diagnostic Instrument).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040913
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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