510(k) · Cleared
ClearedOne UP Disposable Keratome Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moria, Inc. · HNO Keratome, Ac-Powered
Cleared on Aug 25, 1998 as substantially equivalent to K974004 (Lasersight Technologies, Inc., 1998) and 1 other predicate after a 99-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Aug 25, 1998
- Review
- 99 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935342 (1994). 7 ancestors in all, the oldest K860001 (1986). 3 later devices descend from it, 1 citing it directly.
- 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 deviceK981742 One UP Disposable Keratome HeadMoria, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK040297 Oneuse- Plus MicrokeratomeMoria SA · 2004
- Descendant · 2 generations on · 1 of its ownK043183 EPI-KMoria SA · 2005
- Descendant · 3 generations on · 0 of its ownK172994 EPI K ConsoleMoria SA · 2017
Most influential descendants
Showing 3 of 3 · See allView 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) | K981742 | One UP Disposable Keratome Head | Moria, Inc. | 1998 | — |
| +1 | K040297 | Oneuse- Plus Microkeratome | Moria SA | 2004 | — |
| +2 | K043183 | EPI-K | Moria SA | 2005 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 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
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 |
|---|---|---|---|
| * | K974004 | Automated Disposable Keratome (Adk)Summary page 1…ad Substantial equivalence is being claimed to the following legally marketed devices 1) Automated disposable keratome Company . LASERSIGHT Technologies, Inc. _ 510K K 974 004 2) PLANCON microlamellar keratome (single piece head) Company : PLANCON INSTRUMENTS 510K K970 377 May 18, 1998… | 1998 |
| * | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)Summary page 1…disposable keratome Company . LASERSIGHT Technologies, Inc. _ 510K K 974 004 2) PLANCON microlamellar keratome (single piece head) Company : PLANCON INSTRUMENTS 510K K970 377 May 18, 1998 Premarket Notification Section 5 page 2 MORIA ONE UP disposable keratome head 5. Device descriptio… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040297 | Oneuse- Plus Microkeratome | 2004 | 2 |
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 7 ancestors has a recall.
- Of its descendants, K040297 (Moria SA, 2004) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K974004.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HNO
1in 2018
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNO
7in 2024
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?
The ONE UP disposable keratome head is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of 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/K981742 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981742: One UP Disposable Keratome Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981742
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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