510(k) Report

510(k) · Cleared

Cleared

MB 105 Millennium Blades

K041110510(k) TraditionalCleared Oct 13, 2004168-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

Millennium Biomedical, Inc. · HNO Keratome, Ac-Powered

Cleared on Oct 13, 2004 as substantially equivalent to K002191 (Moria, Inc., 2000) and 3 other predicates after a 168-day review. Its family tree reaches back 2 generations to 2000.

Decided
Oct 13, 2004
Review
168 days
Class
Class I
Product code
HNO
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K002191 (2000). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2002: 1 other ancestorK002191 · Carriazo Barraquer II Microkeratome · Moria, Inc. · 2000K030401 · Disposable M2-PE Microkeratome Blades · Oasis Medical, Inc. · 20032000200220042006
Other ancestors, by generation 1 generation back: 2 other ancestors K030401 · Disposable M2-PE Microkeratome Blades · Oasis Medical, Inc. · 2003K002191 · Carriazo Barraquer II Microkeratome · Moria, Inc. · 20000
  1. Root · 2 generations backK002191 Carriazo Barraquer II MicrokeratomeMoria, Inc. · 2000
  2. 1 generation backK030401 Disposable M2-PE Microkeratome BladesOasis Medical, Inc. · 2003
  3. This deviceK041110 MB 105 Millennium BladesMillennium Biomedical, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002191Carriazo Barraquer II MicrokeratomeMoria, Inc.2000—
−1K030401Disposable M2-PE Microkeratome BladesOasis Medical, Inc.2003—
0 (this device)K041110MB 105 Millennium BladesMillennium Biomedical, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
FIG. 1 — Lineage of K041110, 2000–2004Source: 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? (4)

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
*K002191Carriazo Barraquer II Microkeratome
Summary page 1
…ence is being claimed: Company Device 5 10(k) No. Date Cleared Moria S.A Morina M2 Non- K002191 (blade) 10-12-2000 Disposable Microkeratome M…
Moria, Inc.2000—
*K022982Med-Logics Microkeratome Blade, Model 7050CLB
Summary page 1
…) 10-12-2000 Disposable Microkeratome Med-Logics, Inc Med-Logics K022982 11-15-2002 Microkeratome Blade, Model 7050clb…
Med-Logics, Inc.2002—
*K030401Disposable M2-PE Microkeratome Blades
Summary page 1
…11-15-2002 Microkeratome Blade, Model 7050clb Oasis Medical, Inc Disposable M2-Pe K030401 06-19-2003 Microkeratome Blades…
Oasis Medical, Inc.2003—
*K033236Prizm Keratome Blade, Model MK8512M2
Summary page 2
…May 22, 2001 MB 105 Millennium Blades Premarket Notification Surgin Surgical Prizm Keratome K033236 03-26-2004 Instrumentation, Inc Blade, Model Mk8512mn2 4. A description o…
Surgin Surgical Instrumentation, Inc.2004—

Also cleared against K002191: 6 other devices →

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 4 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • None of the 4 ancestors has a recall.
  • 6 other devices also cite its predicate K002191.

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 MB 105 Millennium blade is intended to be used as a replacement blade for the

Moria M2 Non-Disposable Microkeratome.

Indications for use as stated in the FDA summary.

Also cleared against K002191

6 other devices cite the same predicate.

  • K032836M3 MicrokeratomeMoria SA · 2004
  • K033457M2 Compatible Microkeratome BladeMicro Specialties, Inc. · 2004
  • K040297Oneuse- Plus MicrokeratomeMoria SA · 2004
  • K030401Disposable M2-PE Microkeratome BladesOasis Medical, Inc. · 2003
  • K030891Surgistar Microkeratome Blade, Model NO. 2400-LSKSurgistar, Inc. · 2003
  • K022560M2 Single Use MicrokertomeMoria SA · 2002

More from Millennium Biomedical, Inc.

5 FDA decisions under this applicant name. See the company

  • K020122MB 102 Millennium BladesMillennium Biomedical, Inc. · 2002
  • K011833MB 103 Millennium BladesMillennium Biomedical, Inc. · 2002
  • K003143Millennium Blades, Model MB101Millennium Biomedical, Inc. · 2000
  • K001806Refractive Surgery BladesMillennium Biomedical, Inc. · 2000

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/K041110 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041110: MB 105 Millennium Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041110

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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