510(k) · Cleared
ClearedSurgistar Microkeratome Blade, Model NO. 2400-LSK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgistar, Inc. · HNO Keratome, Ac-Powered
Cleared on Jun 17, 2003 as substantially equivalent to K970377 (Plancon Instruments, 1997) and 2 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jun 17, 2003
- Review
- 88 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935342 (1994). 8 ancestors in all, the oldest K913697 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
- 3 generations backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
- 2 generations backK980924 Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
- 1 generation backK981741 Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
- This deviceK030891 Surgistar Microkeratome Blade, Model NO. 2400-LSKSurgistar, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935342 | SCMD Keratome | S.C.M.D. Keratomes of Arizona | 1994 | — |
| −3 | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) | Plancon Instruments | 1997 | — |
| −2 | K980924 | Plancon Microlamellar Keratome Evolution | Plancon Instruments | 1998 | — |
| −1 | K981741 | Carriazo Barraquer Microkeratome | Moria, Inc. | 1998 | — |
| 0 (this device) | K030891 | Surgistar Microkeratome Blade, Model NO. 2400-LSK | Surgistar, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)Summary page 1…KERATOME; LSK-1 Keratome (Blade only) Manufacturer: PLANCON INSTRUMENTS (Moria, Inc.) 510(k) Number: K970377 Description of the Device: The Surgistar 2400-LSK is a replacement microkeratome blade for the Moria LSK- ONE Keratome. The bla… | 1997 |
| * | K981741 | Carriazo Barraquer MicrokeratomeSummary page 3…ARRIAZO BARRAQUER MICROKERATOME (Blade only) Manufacturer: MORIA, Inc. 510(k) Number: K981741 Description of the Device: The Surgistar 24 10-CB is a replacement microkeratome blade for the Moria Carriazo Barraquer Keratom… | 1998 |
| * | K002191 | Carriazo Barraquer II Microkeratome | 2000 |
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 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 8 ancestors has a recall.
- 6 other devices also cite its predicate K970377.
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 Surgistar 2420-M2 Microkeratome is indicated for use as a replacement blade in the Moria M2 Microkeratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea. The Surgistar 2400-LSK Microkeratome is indicated for use as a replacement blade in the Moria LSK-ONE Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.…
Read the full statement (103 words)
The Surgistar 2420-M2 Microkeratome is indicated for use as a replacement blade in the Moria M2 Microkeratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
The Surgistar 2400-LSK Microkeratome is indicated for use as a replacement blade in the Moria LSK-ONE Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
The Surgistar 2410-CB Microkeratome is indicated for use as a replacement blade in the Moria Carriazo Barraquer Microkeratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030891: Surgistar Microkeratome Blade, Model NO. 2400-LSK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030891
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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