510(k) · Cleared
ClearedBarraquer-Krumeich Refractive Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Optics · HNO Keratome, Ac-Powered
Cleared on Feb 4, 1986 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 70 later devices descend from it.
- Decided
- Feb 4, 1986
- Review
- 33 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 0
70 later devices descend from it, 2 citing it directly.
- This deviceK860001 Barraquer-Krumeich Refractive SetAmerican Medical Optics · 1986
- Descendant · cites it directly · 59 of its ownK990227 Ultrashaper KeratomeLasersight Technologies, Inc. · 2000
- Descendant · 2 generations on · 58 of its ownK032910 Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004
- Descendant · 3 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- Descendant · 4 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 5 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K990227Ultrashaper KeratomeLasersight Technologies, Inc. · 2000 · cites it directly59descendants
- K032910Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004 · 2 generations on58descendants
- K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 3 generations on56descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 4 generations on51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 5 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860001 | Barraquer-Krumeich Refractive Set | American Medical Optics | 1986 | — |
| +1 | K990227 | Ultrashaper Keratome | Lasersight Technologies, Inc. | 2000 | — |
| +2 | K032910 | Carriazo Pendular | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2004 | — |
| +3 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| +4 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +5 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (70)
See all 702 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, K990227 (Lasersight Technologies, Inc., 2000) has gone furthest, with 59 descendants 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 | — |
https://510kreport.com/device/K860001 · printed Nov 4, 2026
Cite this page
510(k) Report. “K860001: Barraquer-Krumeich Refractive Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860001
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026