510(k) · Cleared

Cleared

MB 102 Millennium Blades

K020122510(k) TraditionalCleared Feb 15, 200232-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 Feb 15, 2002 as substantially equivalent to K972808 (Chiron Vision Corp., 1997) after a 32-day review. Its family tree reaches back 2 generations to 1991.

Decided: Feb 15, 2002
Review: 32 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K913697 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
1 generation backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
This deviceK020122 MB 102 Millennium BladesMillennium Biomedical, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K913697	Automatic Corneal Shaper	Hansa Research & Development, Inc.	1991	—
−1	K972808	Hansatome Microkeratome	Chiron Vision Corp.	1997	—
0 (this device)	K020122	MB 102 Millennium Blades	Millennium Biomedical, Inc.	2002	—

FIG. 1 — Lineage of K020122, 1991–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K972808	Hansatome Microkeratome Summary page 2 …redicate device or legally marketed device or devices to which substantial equivalence is being claimed: Company Device 510(k) No. Date Cleared Chiron Vision Hansatome™ K972808 11-5-91 (Bausch & Lomb) Microkeratome which uses Bausch & Lomb Accuglide™ blades 238 Millennium Biomedical Inc…	Chiron Vision Corp.	1997	—

Also cleared against K972808: 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 11 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
None of the 2 ancestors has a recall.
6 other devices also cite its predicate K972808.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	2	32
2008	1	—	2	31
2009	1	—	0	85
2010	0	—	0	84
2011	0	—	4	90
2012	0	—	0	100
2013	0	—	0	353
2014	0	—	0	452
2015	0	—	0	966
2016	0	—	0	1,397
2017	1	—	0	2,112
2018	1	—	0	2,265
2019	0	—	0	816
2020	0	—	0	405
2021	0	—	0	72
2022	0	—	0	7
2023	0	—	0	10
2024	0	—	0	7
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The MB 102 Millennium blade is intended to be used as a replacement blade for the

Chiron Hansatome™ Microkeratome.

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

https://510kreport.com/device/K020122 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020122: MB 102 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/K020122

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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