510(k) Report

510(k) · Cleared

Cleared

Opd-Station Software

K050336510(k) TraditionalCleared Aug 24, 2005195-day reviewClass I21 CFR 886.1760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nidek, Inc. · NCF Aberrometer, Ophthalmic

Cleared on Aug 24, 2005 as substantially equivalent to K944207 (Computed Anatomy, Inc., 1994) and 1 other predicate after a 195-day review. Its family tree reaches back 1 generation to 1994.

Decided
Aug 24, 2005
Review
195 days
Class
Class I
Product code
NCF
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K944207 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorK944207 · Topographic Modeling System 2 TMS-2 · Computed Anatomy, Inc. · 19941990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K944207 · Topographic Modeling System 2 TMS-2 · Computed Anatomy, Inc. · 19940
  1. Root · 1 generation backK944207 Topographic Modeling System 2 TMS-2Computed Anatomy, Inc. · 1994
  2. This deviceK050336 Opd-Station SoftwareNidek, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944207Topographic Modeling System 2 TMS-2Computed Anatomy, Inc.1994—
0 (this device)K050336Opd-Station SoftwareNidek, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K050336, 1994–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 NCF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K944207Topographic Modeling System 2 TMS-2
Summary page 1
…g predicate devices: Predicate Device Manufacturer 510(k) No. Date Cleared Topographic Computed Anatomy K944207 Dec. 7, 1994 Modeling System Nidek OPD-Scan Nidek Co. Ltd. K003299 March 9, 2001 ==…
Computed Anatomy, Inc.1994—
*K003299Opd-Scan, Models Ark-10000 and Ark-9000
Summary page 1
…ared Topographic Computed Anatomy K944207 Dec. 7, 1994 Modeling System Nidek OPD-Scan Nidek Co. Ltd. K003299 March 9, 2001 NIDEK INCORPORATED TRADITIONAL PREMARKET 510(k) NOTIe*+F4Ql~…
Nidek Co., Ltd.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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All NCF devices

NCF Aberrometer, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NCF

FDA has decided no NCF device since 2007.

Median 510(k) review, days · NCF

Too few NCF 510(k)s in any year since 2007 to give a median.

Recalls per year · NCF

No recall names NCF since 2007.

Adverse event reports per year · NCF

39in 2025

2016: 222017: 1252018: 1482019: 712020: 532021: 462022: 382023: 362024: 342025: 39
2007high 148 (2018) · low 0 (2007)2025

MAUDE reports naming product code NCF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—022
20170—0125
20180—0148
20190—071
20200—053
20210—046
20220—038
20230—036
20240—034
20250—039
20260—0—

What is it indicated for?

The OPD-Station software is indicated for use in analyzing the comeal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, and to display the data in the form of maps, and manage the data.

Indications for use as stated in the FDA summary.

More from Nidek, Inc.

89 FDA decisions under this applicant name. See the company

  • K042785Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004
  • K031733Non-Contact Tonometer, Model NT-4000Nidek, Inc. · 2003
  • K032085Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 20033 recalls
  • K013694Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
  • K020876Echoscan, Model US-1800Nidek, Inc. · 2002

Recent decisions in NCF

The NCF category page

  • K062930Ladarwave Customcornea Wavefront SystemAlcon Research, Ltd. · 2006
  • K023249Alcon Ladarwave Customcornea Wavefront SystemAlcon Laboratories, Inc. · 20021 recall
  • K000637Customcornea Measurement Device (CCMD)Alcon Laboratories, Inc. · 2000

https://510kreport.com/device/K050336 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050336: Opd-Station Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050336

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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