510(k) · Cleared

Cleared

M3 Microkeratome

K032836510(k) TraditionalCleared Jun 18, 2004281-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 · HNO Keratome, Ac-Powered

Cleared on Jun 18, 2004 as substantially equivalent to K002191 (Moria, Inc., 2000) and 2 other predicates after a 281-day review. Its family tree reaches back 2 generations to 1994.

Decided: Jun 18, 2004
Review: 281 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K935342 (1994). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
1 generation backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
This deviceK032836 M3 MicrokeratomeMoria SA · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K935342	SCMD Keratome	S.C.M.D. Keratomes of Arizona	1994	—
−1	K970377	Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)	Plancon Instruments	1997	—
0 (this device)	K032836	M3 Microkeratome	Moria SA	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1996	1	0
2000	1	0

FIG. 1 — Lineage of K032836, 1994–2004Source: 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? (3)

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 Summary page 1 …the following Device name: CARRIAZO BARRAQUER 1I Microketatome Company name: MORIA S.A. Document control number: K002 191 Device name: Plancon microlamellair Keratome Company name: PLANCON INSTRUMENTS…	Moria, Inc.	2000	—
*	K970377	Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) Summary page 1 …002 191 Device name: Plancon microlamellair Keratome Company name: PLANCON INSTRUMENTS Document control number: K970377 Device name: Automatic Comeal Shaper Surgical Instrument Company name: CHIRON VISIO…	Plancon Instruments	1997	—
*	K941550	Automatic Corneal Shaper Surgical Instrument Summary page 1 …Device name: Automatic Comeal Shaper Surgical Instrument Company name: CHIRON VISION CORP. Document control number: K941550 September 1U"', zuui MORIA S.A.…	Chiron Vision Corp.	1994	—
†	K003594	Carriazo Barraquer Single Use Microkeratome	Moria, Inc.	2001	—

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 10 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
None of the 5 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

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 M3 microkeratome is intended for use in the making of a comeal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032836 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032836: M3 Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032836

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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