510(k) · Cleared

Cleared

Automated Disposable Keratome (Adk)

K974004510(k) TraditionalCleared Jan 8, 199879-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

Lasersight Technologies, Inc. · HNO Keratome, Ac-Powered

Cleared on Jan 8, 1998 as substantially equivalent to K941550 (Chiron Vision Corp., 1994) and 2 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1986. 9 later devices descend from it.

Decided: Jan 8, 1998
Review: 79 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K860001 (1986). 3 ancestors in all. 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK860001 Barraquer-Krumeich Refractive SetAmerican Medical Optics · 1986
This deviceK974004 Automated Disposable Keratome (Adk)Lasersight Technologies, Inc. · 1998
Descendant · cites it directly · 3 of its ownK981742 One UP Disposable Keratome HeadMoria, Inc. · 1998
Descendant · 2 generations on · 2 of its ownK040297 Oneuse- Plus MicrokeratomeMoria SA · 2004
Descendant · cites it directly · 2 of its ownK990900 Microkeratome, Model MK-2000Nidek, Inc. · 1999
Descendant · 3 generations on · 1 of its ownK043183 EPI-KMoria SA · 2005
Descendant · cites it directly · 1 of its ownK983317 Barron Microkeratome System, Model B2000Barron Precision Instruments, LLC · 1998

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

1998high 2 (1998) · low 0 (2001)2026

Most influential descendants

Showing 5 of 9 · See all

K981742One UP Disposable Keratome HeadMoria, Inc. · 1998 · cites it directly3descendants
K040297Oneuse- Plus MicrokeratomeMoria SA · 2004 · 2 generations on2descendants
K990900Microkeratome, Model MK-2000Nidek, Inc. · 1999 · cites it directly2descendants
K043183EPI-KMoria SA · 2005 · 3 generations on1descendant
K983317Barron Microkeratome System, Model B2000Barron Precision Instruments, LLC · 1998 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K860001	Barraquer-Krumeich Refractive Set	American Medical Optics	1986	—
0 (this device)	K974004	Automated Disposable Keratome (Adk)	Lasersight Technologies, Inc.	1998	—
+1	K981742	One UP Disposable Keratome Head	Moria, Inc.	1998	—
+2	K040297	Oneuse- Plus Microkeratome	Moria SA	2004	—
+1	K990900	Microkeratome, Model MK-2000	Nidek, Inc.	1999	—
+3	K043183	EPI-K	Moria SA	2005	—
+1	K983317	Barron Microkeratome System, Model B2000	Barron Precision Instruments, LLC	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0
2000	1	0
2002	1	0
2003	1	0
2004	1	0
2005	1	0
2017	1	0

FIG. 1 — Lineage of K974004, 1986–2017Source: 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
*	K941550	Automatic Corneal Shaper Surgical Instrument Summary page 1 …to the following predicate devices: o Automatic Corneal Shaper, manufactured and distributed by Chiron Vision Corporation, 9342 Jeronimo Road, Irvine, CA [cleared under K941550]. \| o Steinway-Barraquer In-Situ Microkeratome Set, manufactured and distributed by Steinway Instrument Company, Inc., San Diego…	Chiron Vision Corp.	1994	—
*	K860001	Barraquer-Krumeich Refractive Set Summary page 1 …distributed by Steinway Instrument Company, Inc., San Diego, CA. This device is identical to the Allergan Medical Optics Barraquer-Krumeich Refractive Set [cleared under K860001]. e Micro Refractive System Model 1000, manufactured and distributed by Micro Precision Instrument Company, 2323 N. Central Aven…	American Medical Optics	1986	—
*	K903912	Keratome Summary page 1 …e Micro Refractive System Model 1000, manufactured and distributed by Micro Precision Instrument Company, 2323 N. Central Avenue, Suite 2105, Phoenix, AZ [cleared under K903912]. Descriptions of Subject Device: Device Description: The Automated Disposable Keratome consists of two compom?n…	Micro Precision Instrument Co.	1990	—

Also cleared against K941550: 4 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K981742	One UP Disposable Keratome Head	Moria, Inc.	1998	3
K990900	Microkeratome, Model MK-2000	Nidek, Inc.	1999	2
K983317	Barron Microkeratome System, Model B2000	Barron Precision Instruments, LLC	1998	1

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 3 ancestors has a recall.
Of its descendants, K981742 (Moria, Inc., 1998) has gone furthest, with 3 descendants of its own.
4 other devices also cite its predicate K941550.

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?

ADK (Automated Disposable Keratome) is intended to perform anterior, lameliar, circular corneal resections of a predetermined diameter and thickness.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974004 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974004: Automated Disposable Keratome (Adk).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974004

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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