510(k) · Cleared
ClearedCbalk-1000 Blade
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howard Instruments, Inc. · HNO Keratome, Ac-Powered
Cleared on Oct 10, 1997 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Oct 10, 1997
- Review
- 81 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK972727 Cbalk-1000 BladeHoward Instruments, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK980508 Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D.…Micro Specialties, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK980510 Keratome Blade (135 Micron, Model 300135), (160 Micron, Model…Micro Specialties, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK993122 MSP M/K BladeMedical Sterile Products, Inc. · 2000
Most influential descendants
Showing 3 of 3 · See all- K980508Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome…Micro Specialties, Inc. · 1998 · cites it directly1descendant
- K980510Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron…Micro Specialties, Inc. · 1998 · cites it directly1descendant
- K993122MSP M/K BladeMedical Sterile Products, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972727 | Cbalk-1000 Blade | Howard Instruments, Inc. | 1997 | — |
| +1 | K980508 | Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model… | Micro Specialties, Inc. | 1998 | — |
| +1 | K980510 | Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200… | Micro Specialties, Inc. | 1998 | — |
| +1 | K993122 | MSP M/K Blade | Medical Sterile Products, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 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?
- Of its descendants, K980508 (Micro Specialties, Inc., 1998) has gone furthest, with 1 descendant of its own.
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 CBALK-1000 blades are to be used with the Chiron Microkeratome.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972727 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972727: Cbalk-1000 Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972727
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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