510(k) · Cleared

Cleared

Keratome System

K974243510(k) TraditionalCleared Jan 20, 199869-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

Insight Technologies Instruments, LLC · HMY Keratome, Battery-Powered

Cleared on Jan 20, 1998 as substantially equivalent to K970377 (Plancon Instruments, 1997) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 1994.

Decided: Jan 20, 1998
Review: 69 days
Class: Class I
Product code: HMY
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K935342 (1994). 3 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 deviceK974243 Keratome SystemInsight Technologies Instruments, LLC · 1998

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)	K974243	Keratome System	Insight Technologies Instruments, LLC	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K974243, 1994–1998Source: 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 HMY? 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? (2)

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
*	K970377	Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) Summary page 2 …in design construction, and function to the devices as marketed by: ¢ Plancon Instruments, ANTONY FRANCE 92160 Lamellar Keratoplasty System Model LK.S. Reference 510k: K970377 e S.CM.D. Keratomes of Arizona, FTN. HILLS, AZ 85268 TurboKeratome System by SCMD Model MLK Reference 510k: K935342 Descriptive…	Plancon Instruments	1997	—
*	K935342	SCMD Keratome Summary page 2 …llar Keratoplasty System Model LK.S. Reference 510k: K970377 e S.CM.D. Keratomes of Arizona, FTN. HILLS, AZ 85268 TurboKeratome System by SCMD Model MLK Reference 510k: K935342 Descriptive Comparison: Refer to “Attachment 1” for similarities and differences between the Insight Technologies Instruments L…	S.C.M.D. Keratomes of Arizona	1994	—

Also cleared against K970377: 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 4 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
None of the 3 ancestors has a recall.
6 other devices also cite its predicate K970377.

How does its category compare?

All HMY devices

HMY Keratome, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HMY

FDA has decided no HMY device since 2007.

Median 510(k) review, days · HMY

Too few HMY 510(k)s in any year since 2007 to give a median.

Recalls per year · HMY

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HMY

1in 2025

2007high 13 (2020) · low 0 (2011)2025

MAUDE reports naming product code HMY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	1	1
2008	—	0	2
2009	—	0	2
2010	—	0	1
2011	—	0	0
2012	—	0	0
2013	—	0	1
2014	—	0	1
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	13
2021	—	0	7
2022	—	0	2
2023	—	0	1
2024	—	0	2
2025	—	0	1
2026	—	0	—

What is it indicated for?

The Insight Technologies Instruments, Model K-1000 Keratome System is designed to produce a corneal flap.

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/K974243 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974243: Keratome System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974243

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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