510(k) · Cleared

Cleared

SCMD Keratome

K935342510(k) TraditionalCleared Apr 1, 1994147-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

S.C.M.D. Keratomes of Arizona · HNO Keratome, Ac-Powered

Cleared on Apr 1, 1994 after a 147-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 77 later devices descend from it.

Decided: Apr 1, 1994
Review: 147 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 0

77 later devices descend from it, 2 citing it directly.

This deviceK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
Descendant · cites it directly · 76 of its ownK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
Descendant · 2 generations on · 66 of its ownK980924 Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
Descendant · 3 generations on · 63 of its ownK981741 Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
Descendant · 3 generations on · 58 of its ownK032910 Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004
Descendant · 4 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

1997high 8 (2012) · low 0 (2001)2026

Most influential descendants

Showing 5 of 77 · See all

K970377Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)Plancon Instruments · 1997 · cites it directly76descendants
K980924Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998 · 2 generations on66descendants
K981741Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998 · 3 generations on63descendants
K032910Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004 · 3 generations on58descendants
K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 4 generations on56descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	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	—
+2	K980924	Plancon Microlamellar Keratome Evolution	Plancon Instruments	1998	—
+3	K981741	Carriazo Barraquer Microkeratome	Moria, Inc.	1998	—
+3	K032910	Carriazo Pendular	Schwind Eye-Tech-Solutions GmbH & Co. KG	2004	—
+4	K073404	Ifs Laser System	Intra Lase Corp.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1998	5	0
1999	2	0
2000	1	0
2002	2	0
2003	2	0
2004	3	0
2005	1	0
2008	2	0
2009	2	0
2010	5	0
2011	4	0
2012	8	0
2013	2	0
2014	4	0
2015	6	0
2016	2	0
2017	7	0
2018	6	0
2019	1	0
2020	2	0
2021	1	0
2022	3	0
2023	2	0
2025	2	0

FIG. 1 — Lineage of K935342, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (77)

See all 77

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K970377	Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)	Plancon Instruments	1997	76
K974243	Keratome System	Insight Technologies Instruments, LLC	1998	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?

Of its descendants, K970377 (Plancon Instruments, 1997) has gone furthest, with 76 descendants of its own.

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	—

https://510kreport.com/device/K935342 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935342: SCMD Keratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935342

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026