510(k) · Cleared

Cleared

Carriazo Pendular

K032910510(k) TraditionalCleared Aug 30, 2004343-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

Schwind Eye-Tech-Solutions GmbH & Co. KG · HNO Keratome, Ac-Powered

Cleared on Aug 30, 2004 as substantially equivalent to K981741 (Moria, Inc., 1998) and 5 other predicates after a 343-day review. Its family tree reaches back 4 generations to 1994. 58 later devices descend from it.

Decided: Aug 30, 2004
Review: 343 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 6

Its longest line of descent runs back 4 generations to K935342 (1994). 14 ancestors in all, the oldest K860001 (1986). 58 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
3 generations backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
2 generations backK980924 Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
1 generation backK981741 Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
This deviceK032910 Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004
Descendant · cites it directly · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
Descendant · 2 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
Descendant · 3 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
Descendant · 3 generations on · 31 of its ownK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
Descendant · 3 generations on · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2008high 8 (2012) · low 0 (2024)2026

Most influential descendants

Showing 5 of 58 · See all

K073404Ifs Laser SystemIntra Lase Corp. · 2008 · cites it directly56descendants
K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 2 generations on51descendants
K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 3 generations on47descendants
K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 3 generations on31descendants
K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · 3 generations on30descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K935342	SCMD Keratome	S.C.M.D. Keratomes of Arizona	1994	—
−3	K970377	Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)	Plancon Instruments	1997	—
−2	K980924	Plancon Microlamellar Keratome Evolution	Plancon Instruments	1998	—
−1	K981741	Carriazo Barraquer Microkeratome	Moria, Inc.	1998	—
0 (this device)	K032910	Carriazo Pendular	Schwind Eye-Tech-Solutions GmbH & Co. KG	2004	—
+1	K073404	Ifs Laser System	Intra Lase Corp.	2008	—
+2	K082947	Lensx 550 Laser System	Lensx Lasers, Inc.	2009	—
+3	K094052	Lensx 550 Laser System. Model 550	Lensx Lasers, Inc.	2010	—
+3	K092647	Lensx 550 Laser System	Lensx Lasers, Inc.	2009	—
+3	K101626	Lensx Laser System	Lensx Lasers, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1990	1	0
1991	1	0
1994	1	0
1996	1	0
1997	1	0
2000	1	0
2001	1	0
2002	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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	6	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 K032910, 1994–2025Source: 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

Get a 510(k) Report

What was it cleared against? (6)

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
*	K981741	Carriazo Barraquer Microkeratome Summary page 1 …ion: 21 CFR 886.4370 Class I Product Code: HNO Panel: 86 Predicate devices: Carriazo Barraquer Microkeratome M2 (K981741); Hansatome Micro- keratome (K972808); Plancon Microlamellar Keratome (K980924); Hansatome…	Moria, Inc.	1998	—
*	K972808	Hansatome Microkeratome Summary page 1 …Product Code: HNO Panel: 86 Predicate devices: Carriazo Barraquer Microkeratome M2 (K981741); Hansatome Micro- keratome (K972808); Plancon Microlamellar Keratome (K980924); Hansatome Excellus (K021640); UltraShaper System (K990227); Visito…	Chiron Vision Corp.	1997	—
*	K980924	Plancon Microlamellar Keratome Evolution Summary page 1 …Panel: 86 Predicate devices: Carriazo Barraquer Microkeratome M2 (K981741); Hansatome Micro- keratome (K972808); Plancon Microlamellar Keratome (K980924); Hansatome Excellus (K021640); UltraShaper System (K990227); Visitone 20-10 Microkeratome…	Plancon Instruments	1998	—
*	K021640	Hansatome Excellus Microkeratome Summary page 1 …quer Microkeratome M2 (K981741); Hansatome Micro- keratome (K972808); Plancon Microlamellar Keratome (K980924); Hansatome Excellus (K021640); UltraShaper System (K990227); Visitone 20-10 Microkeratome (K014000). Indications: The…	Bausch & Lomb, Inc.	2002	—
*	K990227	Ultrashaper Keratome Summary page 1 …); Hansatome Micro- keratome (K972808); Plancon Microlamellar Keratome (K980924); Hansatome Excellus (K021640); UltraShaper System (K990227); Visitone 20-10 Microkeratome (K014000). Indications: The Carriazo Pendular Microkerato…	Lasersight Technologies, Inc.	2000	—
*	K014000	Vistitome 20-10 Microkeratome Summary page 1 …Plancon Microlamellar Keratome (K980924); Hansatome Excellus (K021640); UltraShaper System (K990227); Visitone 20-10 Microkeratome (K014000). Indications: The Carriazo Pendular Microkeratome is indicated for shaving the cornea p…	Biovision AG	2002	—

Also cleared against K981741: 2 other devices →

What descends from it? (58)

See all 58

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

Number	Device	Applicant	Decided	Descendants
K073404	Ifs Laser System	Intra Lase Corp.	2008	56
K101006	Wavelight FS200 Laser System Model: FS200	Alcon Research, Ltd.	2010	21
K082043	Carriazo-Pendular Microkeratome	Schwind Eye-Tech-Solutions GmbH & Co. KG	2008	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?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
None of the 14 ancestors has a recall.
Of its descendants, K073404 (Intra Lase Corp., 2008) has gone furthest, with 56 descendants of its own.
2 other devices also cite its predicate K981741.

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 Carriazo Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032910 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032910: Carriazo Pendular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032910

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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