510(k) Report

510(k) · Cleared

Cleared

Microkeratome, Model MK-2000

K990900510(k) TraditionalCleared Sep 24, 1999190-day reviewClass I21 CFR 886.4370

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

Nidek, Inc. · HNO Keratome, Ac-Powered

Cleared on Sep 24, 1999 as substantially equivalent to K913697 (Hansa Research & Development, Inc., 1991) and 5 other predicates after a 190-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.

Decided
Sep 24, 1999
Review
190 days
Class
Class I
Product code
HNO
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K935342 (1994). 14 ancestors in all, the oldest K843646 (1985). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors1997: 2 other ancestors1991: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1990: 1 other ancestor1986: 1 other ancestor1985: 1 other ancestor2003: 1 descendant cleared2002: 1 descendant clearedK935342 · SCMD Keratome · S.C.M.D. Keratomes of Arizona · 1994K970377 · Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) · Plancon Instruments · 1997×2: 2 generations cleared close together, K980924 (1998), K981741 (1998) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 5 other ancestors 1 generation forward: 2 descendants K981741 · Carriazo Barraquer Microkeratome · Moria, Inc. · 1998K980924 · Plancon Microlamellar Keratome Evolution · Plancon Instruments · 1998K970377 · Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) · Plancon Instruments · 1997K935342 · SCMD Keratome · S.C.M.D. Keratomes of Arizona · 19940
  1. Root · 4 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
  2. 3 generations backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
  3. 2 generations backK980924 Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
  4. 1 generation backK981741 Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
  5. This deviceK990900 Microkeratome, Model MK-2000Nidek, Inc. · 1999
  6. Descendant · cites it directly · 0 of its ownK032297 Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003
  7. Descendant · cites it directly · 0 of its ownK022205 Disposable N-PE Microkeratome BladesOasis Medical, Inc. · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003 · cites it directly0descendants
  • K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K935342SCMD KeratomeS.C.M.D. Keratomes of Arizona1994—
−3K970377Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)Plancon Instruments1997—
−2K980924Plancon Microlamellar Keratome EvolutionPlancon Instruments1998—
−1K981741Carriazo Barraquer MicrokeratomeMoria, Inc.1998—
0 (this device)K990900Microkeratome, Model MK-2000Nidek, Inc.1999—
+1K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc.2003—
+1K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198610
199010
199110
199410
199610
199720
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
FIG. 1 — Lineage of K990900, 1994–2003Source: 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 HNO? 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? (6)

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
*K913697Automatic Corneal Shaper
Our OCR of the scanned summary read K912697, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AUTOMATED CORNEAL SHAPER”.
Hansa Research & Development, Inc.1991—
*K972808Hansatome Microkeratome
Summary page 1
…lent to the following currently Marketed Predicate Devices: Submitter Model 510(k) Number Date Hansa R&D* AUTOMATED CORNEAL SHAPER K912697 05-Nov-91 Hansa R&D HANSATOME K972808 24-Oct-97 Innovative Optics INNOVATOME K973294 03-Oct-97 MORIA CARRAZIO BARRAQUER K981141 24-Jul-98 Hawken Industries FLAPMAKER…
Chiron Vision Corp.1997—
*K973294Innovatome Microkeratome
Summary page 1
…te Devices: Submitter Model 510(k) Number Date Hansa R&D* AUTOMATED CORNEAL SHAPER K912697 05-Nov-91 Hansa R&D HANSATOME K972808 24-Oct-97 Innovative Optics INNOVATOME K973294 03-Oct-97 MORIA CARRAZIO BARRAQUER K981141 24-Jul-98 Hawken Industries FLAPMAKER K981155 14-Aug-98 LaserSight Tech. ADK K974004 0…
Innovative Optics, Inc.1997—
*K981741Carriazo Barraquer Microkeratome
Our OCR of the scanned summary read K981141, FDA’s number for Sargon Immediate Load Implant, Model D (Sargon Ent., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CARRAZIO BARRAQUER”.
Moria, Inc.1998—
*K981155Flapmaker Disposable Microkeratome
Summary page 1
…97 05-Nov-91 Hansa R&D HANSATOME K972808 24-Oct-97 Innovative Optics INNOVATOME K973294 03-Oct-97 MORIA CARRAZIO BARRAQUER K981141 24-Jul-98 Hawken Industries FLAPMAKER K981155 14-Aug-98 LaserSight Tech. ADK K974004 08-Jan-98 * The 510(k) for the AUTOMATED CORNEAL SHAPER was submitted by Hansa Research a…
Hawken Industries1998—
*K974004Automated Disposable Keratome (Adk)
Summary page 1
…8 24-Oct-97 Innovative Optics INNOVATOME K973294 03-Oct-97 MORIA CARRAZIO BARRAQUER K981141 24-Jul-98 Hawken Industries FLAPMAKER K981155 14-Aug-98 LaserSight Tech. ADK K974004 08-Jan-98 * The 510(k) for the AUTOMATED CORNEAL SHAPER was submitted by Hansa Research and Development, Inc., but his product i…
Lasersight Technologies, Inc.1998—

Also cleared against K913697: 6 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc.20030
K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc.20020

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 5 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
  • None of the 14 ancestors has a recall.
  • Of its descendants, K032297 (Oasis Medical, Inc., 2003) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K913697.

How does its category compare?

All HNO devices

HNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HNO

1in 2018

2008: 12009: 12017: 12018: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HNO

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

Recalls per year · HNO

4in 2011

2007: 22008: 22011: 4
2007high 4 (2011) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HNO

7in 2024

2007: 322008: 312009: 852010: 842011: 902012: 1002013: 3532014: 4522015: 9662016: 1,3972017: 2,1122018: 2,2652019: 8162020: 4052021: 722022: 72023: 102024: 7
2007high 2,265 (2018) · low 0 (2025)2025

MAUDE reports naming product code HNO, 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—232
20081—231
20091—085
20100—084
20110—490
20120—0100
20130—0353
20140—0452
20150—0966
20160—01,397
20171—02,112
20181—02,265
20190—0816
20200—0405
20210—072
20220—07
20230—010
20240—07
20250—00
20260—0—

What is it indicated for?

The Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a predetermined thickness and diameter using a high speed oscillation blade of stainless steel.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K913697

6 other devices cite the same predicate.

  • K991124Visijet Hydrokeratome, Model 50Visijet, Inc. · 2000
  • K993190Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)Surgical Instrument Systems (Sis), Ltd. · 2000
  • K983317Barron Microkeratome System, Model B2000Barron Precision Instruments, LLC · 1998
  • K981155Flapmaker Disposable MicrokeratomeHawken Industries · 1998
  • K981741Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
  • K972808Hansatome MicrokeratomeChiron Vision Corp. · 1997

More from Nidek, Inc.

89 FDA decisions under this applicant name. See the company

  • K050336Opd-Station SoftwareNidek, Inc. · 2005
  • 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

Recent decisions in HNO

The HNO category page

  • K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc. · 2018
  • K172994EPI K ConsoleMoria SA · 2017
  • K072102Epivision SL SystemGebauer Medizintechnik GmbH · 2009
  • K082043Carriazo-Pendular MicrokeratomeSchwind Eye-Tech-Solutions GmbH & Co. KG · 2008
  • K062465Zyoptix XP Epi Separator SystemBausch & Lomb, Inc. · 20061 recall

https://510kreport.com/device/K990900 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990900: Microkeratome, Model MK-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990900

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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