510(k) · Cleared
ClearedOneuse- Plus Microkeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moria SA · HMY Keratome, Battery-Powered
Cleared on Mar 31, 2004 as substantially equivalent to K981742 (Moria, Inc., 1998) and 1 other predicate after a 51-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 31, 2004
- Review
- 51 days
- Class
- Class I
- Product code
- HMY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935342 (1994). 9 ancestors in all, the oldest K860001 (1986). 2 later devices descend from it, 1 citing it directly.
- 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 backK981742 One UP Disposable Keratome HeadMoria, Inc. · 1998
- This deviceK040297 Oneuse- Plus MicrokeratomeMoria SA · 2004
- Descendant · cites it directly · 1 of its ownK043183 EPI-KMoria SA · 2005
- Descendant · 2 generations on · 0 of its ownK172994 EPI K ConsoleMoria SA · 2017
Most influential descendants
Showing 2 of 2 · See allView 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 | K981742 | One UP Disposable Keratome Head | Moria, Inc. | 1998 | — |
| 0 (this device) | K040297 | Oneuse- Plus Microkeratome | Moria SA | 2004 | — |
| +1 | K043183 | EPI-K | Moria SA | 2005 | — |
| +2 | K172994 | EPI K Console | Moria SA | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2017 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K981742 | One UP Disposable Keratome HeadSummary page 1…following legally marketed devices: Device name: One Up Disposable keratome Head Company name: MORIA S.A. Document control number: K981742 Device name: CARRIAZO BARRAQUER I! Microkeratome Company name: MORIA S.A. Document control num… | 1998 |
| * | K002191 | Carriazo Barraquer II MicrokeratomeSummary page 1…t control number: K981742 Device name: CARRIAZO BARRAQUER I! Microkeratome Company name: MORIA S.A. Document control number: K002191 MORIA S.A. February 5, 2004 OneUse - Plus Microke… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043183 | EPI-K | 2005 | 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?
- 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 9 ancestors has a recall.
- Of its descendants, K043183 (Moria SA, 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HMY devicesHMY 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HMY
1in 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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OneUse - Plus Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040297: Oneuse- Plus Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040297
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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