510(k) · Cleared
ClearedMSP M/K Blade
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Sterile Products, Inc. · HNO Keratome, Ac-Powered
Cleared on Mar 16, 2000 as substantially equivalent to K980510 (Micro Specialties, Inc., 1998) and 3 other predicates after a 178-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Mar 16, 2000
- Review
- 178 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K962661 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962661 | ML Microkeratome Blade | Med-Logics, Inc. | 1996 | — |
| −1 | K980510 | Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200… | Micro Specialties, Inc. | 1998 | — |
| 0 (this device) | K993122 | MSP M/K Blade | Medical Sterile Products, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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? (5)
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 |
|---|---|---|---|
| * | K980510 | Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron…Summary page 2…sposable microkeratome blades are similar in design and function to those blades marketed by: Microspecialties, Inc. 16 Higgins Drive Milford, CT 06460 510k Number : K980510 (Releasable 510k details attached) K980508 Howard Instruments, Inc. 4749 Appletree Lane Tuscaloosa, AL 35405 510k Number : K9… | 1998 |
| * | K980508 | Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome…Summary page 2…n design and function to those blades marketed by: Microspecialties, Inc. 16 Higgins Drive Milford, CT 06460 510k Number : K980510 (Releasable 510k details attached) K980508 Howard Instruments, Inc. 4749 Appletree Lane Tuscaloosa, AL 35405 510k Number : K972727 (Releasable 510k details attached) M… | 1998 |
| * | K972727 | Cbalk-1000 BladeSummary page 2…Milford, CT 06460 510k Number : K980510 (Releasable 510k details attached) K980508 Howard Instruments, Inc. 4749 Appletree Lane Tuscaloosa, AL 35405 510k Number : K972727 (Releasable 510k details attached) Med-Logics, Inc. 9327 Blackley Street Temple City, CA 91780 510k Number : K962661 (Releasa… | 1997 |
| * | K962661 | ML Microkeratome BladeSummary page 2…letree Lane Tuscaloosa, AL 35405 510k Number : K972727 (Releasable 510k details attached) Med-Logics, Inc. 9327 Blackley Street Temple City, CA 91780 510k Number : K962661 (Releasable 510k details attached) Universal Refractive Instruments B. Graczyk, Inc. 61 Brookside Drive Glendale, IL (Promoti… | 1996 |
| * | — | Universal Refractive Instruments, B. Graczyk, Inc. Named without a submission number |
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 4 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
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 MSP/MK Blade (#507-0028) is designed as a replacement blade
for the Chiron Hansatome #507-0036-01 microkeratome for lamellar
resection of the cornea.
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/K993122 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993122: MSP M/K Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993122
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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