510(k) Report

510(k) · Cleared

Cleared

M2 Single Use Microkertome

K022560510(k) TraditionalCleared Sep 27, 200256-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

Moria SA · HMY Keratome, Battery-Powered

Cleared on Sep 27, 2002 as substantially equivalent to K003594 (Moria, Inc., 2001) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 2000.

Decided
Sep 27, 2002
Review
56 days
Class
Class I
Product code
HMY
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K002191 (2000). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorReference device: K970377 · Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) · Plancon Instruments · 1997K002191 · Carriazo Barraquer II Microkeratome · Moria, Inc. · 2000200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K002191 · Carriazo Barraquer II Microkeratome · Moria, Inc. · 20000
  1. Root · 1 generation backK002191 Carriazo Barraquer II MicrokeratomeMoria, Inc. · 2000
  2. This deviceK022560 M2 Single Use MicrokertomeMoria SA · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002191Carriazo Barraquer II MicrokeratomeMoria, Inc.2000—
0 (this device)K022560M2 Single Use MicrokertomeMoria SA2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K022560, 2000–2002Source: 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 HMY? 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? (2)

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
*K003594Carriazo Barraquer Single Use Microkeratome
Summary page 2
…e power unit used for the M2 SINGLE USE microkeratome is the same as the power unit used for the predicate devices CARRIAZO BARRAQUER SINGLE USE Microkeratome (K003594) & CARRIAZO BARRAQUER I1 Microkeratome (K002191) already legally marketed in the USA by our company. The power uni…
Moria, Inc.2001—
*K002191Carriazo Barraquer II Microkeratome
Summary page 2
…is the same as the power unit used for the predicate devices CARRIAZO BARRAQUER SINGLE USE Microkeratome (K003594) & CARRIAZO BARRAQUER I1 Microkeratome (K002191) already legally marketed in the USA by our company. The power unit includes pumps for producing vacuum. The power…
Moria, Inc.2000—
†K970377Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)Plancon Instruments1997—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All HMY devices

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

FDA decisions per year · HMY

FDA has decided no HMY device since 2007.

Median 510(k) review, days · HMY

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

Recalls per year · HMY

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · HMY

1in 2025

2007: 12008: 22009: 22010: 12013: 12014: 12020: 132021: 72022: 22023: 12024: 22025: 1
2007high 13 (2020) · low 0 (2011)2025

MAUDE reports naming product code HMY, 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—11
20080—02
20090—02
20100—01
20110—00
20120—00
20130—01
20140—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—013
20210—07
20220—02
20230—01
20240—02
20250—01
20260—0—

What is it indicated for?

The M2 SINGLE USE microkeratome is intended for use in the making of a corneal

flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar

resection of the cornea.

Indications for use as stated in the FDA summary.

More from Moria SA

5 FDA decisions under this applicant name. See the company

  • K172994EPI K ConsoleMoria SA · 2017
  • K043183EPI-KMoria SA · 2005
  • K032836M3 MicrokeratomeMoria SA · 2004
  • K040297Oneuse- Plus MicrokeratomeMoria SA · 2004

Recent decisions in HMY

The HMY category page

  • K040297Oneuse- Plus MicrokeratomeMoria SA · 2004
  • K023092BD K-4000 Microkeratome SystemBecton, Dickinson & CO · 20021 recall
  • K022637BD-3000 Microkeratome System, Model K-3000 MicrokeratomeBecton, Dickinson & CO · 20021 recall
  • K003594Carriazo Barraquer Single Use MicrokeratomeMoria, Inc. · 2001
  • K002191Carriazo Barraquer II MicrokeratomeMoria, Inc. · 2000

https://510kreport.com/device/K022560 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022560: M2 Single Use Microkertome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022560

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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