510(k) · Cleared

Cleared

Automatic Corneal Shaper

K913697510(k) TraditionalCleared Nov 5, 199178-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

Hansa Research & Development, Inc. · HNO Keratome, Ac-Powered

Cleared on Nov 5, 1991 after a 78-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 85 later devices descend from it.

Decided: Nov 5, 1991
Review: 78 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 0

85 later devices descend from it, 7 citing it directly.

This deviceK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
Descendant · cites it directly · 80 of its ownK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
Descendant · 2 generations on · 66 of its ownK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
Descendant · 3 generations on · 65 of its ownK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
Descendant · cites it directly · 63 of its ownK981741 Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
Descendant · 4 generations on · 61 of its ownK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled

Showing 5 of 85 descendants. See all descendants

Descendants cleared per year

1997high 8 (2012) · low 0 (2001)2026

Most influential descendants

Showing 5 of 85 · See all

K972808Hansatome MicrokeratomeChiron Vision Corp. · 1997 · cites it directly80descendants
K993153Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · 2 generations on66descendants
K013941Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · 3 generations on65descendants
K981741Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998 · cites it directly63descendants
K031960Intralase FS LaserIntra Lase Corp. · 2003 · 4 generations on61descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K913697	Automatic Corneal Shaper	Hansa Research & Development, Inc.	1991	—
+1	K972808	Hansatome Microkeratome	Chiron Vision Corp.	1997	—
+2	K993153	Intralase 600C Laser Keratome	Intra Lase Corp.	1999	1
+3	K013941	Pulsion FS Laser Keratome	Intra Lase Corp.	2002	1
+1	K981741	Carriazo Barraquer Microkeratome	Moria, Inc.	1998	—
+4	K031960	Intralase FS Laser	Intra Lase Corp.	2003	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	3	0
1999	2	0
2000	2	0
2002	4	0
2003	3	0
2004	4	0
2005	1	0
2006	5	0
2007	1	0
2008	2	0
2009	3	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 K913697, 1991–2025Source: 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

Get a 510(k) Report

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? (85)

See all 85

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

Number	Device	Applicant	Decided	Descendants
K972808	Hansatome Microkeratome	Chiron Vision Corp.	1997	80
K981741	Carriazo Barraquer Microkeratome	Moria, Inc.	1998	63
K981155	Flapmaker Disposable Microkeratome	Hawken Industries	1998	4
K993190	Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)	Surgical Instrument Systems (Sis), Ltd.	2000	2
K990900	Microkeratome, Model MK-2000	Nidek, Inc.	1999	2
K983317	Barron Microkeratome System, Model B2000	Barron Precision Instruments, LLC	1998	1
K991124	Visijet Hydrokeratome, Model 50	Visijet, Inc.	2000	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, K972808 (Chiron Vision Corp., 1997) has gone furthest, with 80 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/K913697 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913697: Automatic Corneal Shaper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913697

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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