510(k) Report

510(k) · Cleared

Cleared

Millennium Blades, Model MB101

K003143510(k) TraditionalCleared Dec 11, 200062-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 Dec 11, 2000 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 11, 2000
Review
62 days
Class
Class I
Product code
HNO
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K003143Source: FDA 510(k) database · 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

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—

More from Millennium Biomedical, Inc.

5 FDA decisions under this applicant name. See the company

  • K041110MB 105 Millennium BladesMillennium Biomedical, Inc. · 2004
  • K020122MB 102 Millennium BladesMillennium Biomedical, Inc. · 2002
  • K011833MB 103 Millennium BladesMillennium Biomedical, Inc. · 2002
  • 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/K003143 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003143: Millennium Blades, Model MB101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003143

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026