510(k) · Cleared
ClearedDisposable N-PE Mickrokeratome Blades
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oasis Medical, Inc. · HNO Keratome, Ac-Powered
Cleared on Aug 26, 2003 as substantially equivalent to K990900 (Nidek, Inc., 1999) after a 32-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Aug 26, 2003
- Review
- 32 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K935342 (1994). 15 ancestors in all, the oldest K843646 (1985). No later device cites it as a predicate yet.
- Root · 5 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
- 4 generations backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
- 3 generations backK980924 Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
- 2 generations backK981741 Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
- 1 generation backK990900 Microkeratome, Model MK-2000Nidek, Inc. · 1999
- This deviceK032297 Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935342 | SCMD Keratome | S.C.M.D. Keratomes of Arizona | 1994 | — |
| −4 | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) | Plancon Instruments | 1997 | — |
| −3 | K980924 | Plancon Microlamellar Keratome Evolution | Plancon Instruments | 1998 | — |
| −2 | K981741 | Carriazo Barraquer Microkeratome | Moria, Inc. | 1998 | — |
| −1 | K990900 | Microkeratome, Model MK-2000 | Nidek, Inc. | 1999 | — |
| 0 (this device) | K032297 | Disposable N-PE Mickrokeratome Blades | Oasis Medical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K990900 | Microkeratome, Model MK-2000Summary page 1…d function to the devices as marketed by: Company Device 51O(k1 Number Nidek Nidek MK-2000 K990900 4. Description of the Device: The OASIS Disposable N-PE Microkeratome Blades are replacement stainless steel blade… | 1999 |
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 9 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 15 ancestors has a recall.
- 1 other device also cites its predicate K990900.
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 OASIS Disposable N-PE Microkeratome Blade is designed as a replacement
blade for the Nidek MK-2000 Microkeratome for lamellar resection of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032297: Disposable N-PE Mickrokeratome Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032297
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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