510(k) · Cleared

Cleared

Disposable M2-PE Microkeratome Blades

K030401510(k) TraditionalCleared Jun 19, 2003133-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

Oasis Medical, Inc. · HNO Keratome, Ac-Powered

Cleared on Jun 19, 2003 as substantially equivalent to K002191 (Moria, Inc., 2000) after a 133-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Jun 19, 2003
Review: 133 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002191 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002191 Carriazo Barraquer II MicrokeratomeMoria, Inc. · 2000
This deviceK030401 Disposable M2-PE Microkeratome BladesOasis Medical, Inc. · 2003
Descendant · cites it directly · 0 of its ownK041110 MB 105 Millennium BladesMillennium Biomedical, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K041110MB 105 Millennium BladesMillennium Biomedical, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002191	Carriazo Barraquer II Microkeratome	Moria, Inc.	2000	—
0 (this device)	K030401	Disposable M2-PE Microkeratome Blades	Oasis Medical, Inc.	2003	—
+1	K041110	MB 105 Millennium Blades	Millennium Biomedical, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K030401, 2000–2004Source: 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
*	K002191	Carriazo Barraquer II Microkeratome	Moria, Inc.	2000	—

Also cleared against K002191: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041110	MB 105 Millennium Blades	Millennium Biomedical, Inc.	2004	0

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?

Its one ancestor has no recall.
Of its descendants, K041110 (Millennium Biomedical, Inc., 2004) has gone furthest, with 0 descendants of its own.
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

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 OASIS Disposable M2-PE (Precision Edge) Microkeratome Blade (Catalog #0415) is designed as a replacement blade for the Moria M2 Microkeratome for lamellar resection of the cornea.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030401 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030401: Disposable M2-PE Microkeratome Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030401

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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