510(k) · Cleared
ClearedFlapmaker Disposable Microkeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hawken Industries · HNO Keratome, Ac-Powered
Cleared on Aug 14, 1998 as substantially equivalent to K941550 (Chiron Vision Corp., 1994) and 2 other predicates after a 136-day review. Its family tree reaches back 1 generation to 1985. 4 later devices descend from it.
- Decided
- Aug 14, 1998
- Review
- 136 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K843646 (1985). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK843646 Steinway Micro-Kerato-TrephineSteinway Instrument Co., Inc. · 1985
- This deviceK981155 Flapmaker Disposable MicrokeratomeHawken Industries · 1998
- Descendant · cites it directly · 2 of its ownK990900 Microkeratome, Model MK-2000Nidek, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK052891 Horizon Epikeratome Disposable Microkeratome SystemHawken Industries · 2006
- Descendant · 2 generations on · 0 of its ownK032297 Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK022205 Disposable N-PE Microkeratome BladesOasis Medical, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K990900Microkeratome, Model MK-2000Nidek, Inc. · 1999 · cites it directly2descendants
- K052891Horizon Epikeratome Disposable Microkeratome SystemHawken Industries · 2006 · cites it directly0descendants
- K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003 · 2 generations on0descendants
- K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843646 | Steinway Micro-Kerato-Trephine | Steinway Instrument Co., Inc. | 1985 | — |
| 0 (this device) | K981155 | Flapmaker Disposable Microkeratome | Hawken Industries | 1998 | — |
| +1 | K990900 | Microkeratome, Model MK-2000 | Nidek, Inc. | 1999 | — |
| +1 | K052891 | Horizon Epikeratome Disposable Microkeratome System | Hawken Industries | 2006 | — |
| +2 | K032297 | Disposable N-PE Mickrokeratome Blades | Oasis Medical, Inc. | 2003 | — |
| +2 | K022205 | Disposable N-PE Microkeratome Blades | Oasis Medical, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (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 | Decided |
|---|---|---|---|
| * | K941550 | Automatic Corneal Shaper Surgical InstrumentSummary page 1…ratome Classification Name: Keratome, A-C powered (3) Equivalent legally-marketed devices: The predicate devices for the FlapMaker are Chiron Automatic Corneal Shaper, K941550, the Steinway Micro-Kerato-trephone K8436646, and the HANSA Automatic Corneal Shaper, K913697. (4) Description The device consi… | 1994 |
| * | K843646 | Steinway Micro-Kerato-Trephine | 1985 |
| * | K913697 | Automatic Corneal ShaperSummary page 1…he predicate devices for the FlapMaker are Chiron Automatic Corneal Shaper, K941550, the Steinway Micro-Kerato-trephone K8436646, and the HANSA Automatic Corneal Shaper, K913697. (4) Description The device consists of a control console and disposable FLAPMAKER™ microkeratomes. The control console contain… | 1991 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.
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/K981155 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981155: Flapmaker Disposable Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981155
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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