510(k) · Cleared

Cleared

Millenium Microkeratome, Model Imd-001

K992687510(k) TraditionalCleared Sep 24, 199945-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

Industrial & Medical Design, Inc. · HMY Keratome, Battery-Powered

Cleared on Sep 24, 1999 as substantially equivalent to K980924 (Plancon Instruments, 1998) and 1 other predicate after a 45-day review. Its family tree reaches back 3 generations to 1994.

Decided: Sep 24, 1999
Review: 45 days
Class: Class I
Product code: HMY
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K935342 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
2 generations backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
1 generation backK980924 Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
This deviceK992687 Millenium Microkeratome, Model Imd-001Industrial & Medical Design, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K935342	SCMD Keratome	S.C.M.D. Keratomes of Arizona	1994	—
−2	K970377	Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)	Plancon Instruments	1997	—
−1	K980924	Plancon Microlamellar Keratome Evolution	Plancon Instruments	1998	—
0 (this device)	K992687	Millenium Microkeratome, Model Imd-001	Industrial & Medical Design, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K992687, 1994–1999Source: 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
*	K980924	Plancon Microlamellar Keratome Evolution Summary page 1 …lassification name: Keratome 8.3. Identification of predicate device. - Company: Plancon Instruments Device: Plancon microlamellar keratome Evolution power unit 510(k) K980924 - Company: Plancon Inctruments Device Plancon microlamellar keratome 510(k) K970377 8.4. Device description. Millenium Microker…	Plancon Instruments	1998	—
*	K970377	Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) Summary page 1 …lancon Instruments Device: Plancon microlamellar keratome Evolution power unit 510(k) K980924 - Company: Plancon Inctruments Device Plancon microlamellar keratome 510(k) K970377 8.4. Device description. Millenium Microkeratome is electrically powered manual mechanical cutting instrument for severing a th…	Plancon Instruments	1997	—

Also cleared against K980924: 3 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 5 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
None of the 4 ancestors has a recall.
3 other devices also cite its predicate K980924.

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?

Millenium Microkeratome is indicated for use in refractive surgery, or other treatment requiring initial lamellar resection of the cornea, circular and 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/K992687 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992687: Millenium Microkeratome, Model Imd-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992687

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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