510(k) · Cleared
ClearedBarraquer-Krumeich Refractive Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eyetech M.V.A. · HNO Keratome, Ac-Powered
Cleared on Nov 6, 1995 after a 154-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 63 later devices descend from it.
- Decided
- Nov 6, 1995
- Review
- 154 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 0
63 later devices descend from it, 1 citing it directly.
- This deviceK954058 Barraquer-Krumeich Refractive SetEyetech M.V.A. · 1995
- Descendant · cites it directly · 62 of its ownK980675 Summit Krumeich-Barraquer MicrokeratomeSummit Technology, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 61 of its ownK013151 Asmotom Automated Trephine SystemBkg Opthalmics USA, Inc. · 2001
- Descendant · 3 generations on · 60 of its ownK041893 Intralase FS LaserIntra Lase Corp. · 2005
- Descendant · 4 generations on · 58 of its ownK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- Descendant · 5 generations on · 57 of its ownK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K980675Summit Krumeich-Barraquer MicrokeratomeSummit Technology, Inc. · 1998 · cites it directly62descendants
- K013151Asmotom Automated Trephine SystemBkg Opthalmics USA, Inc. · 2001 · 2 generations on61descendants
- K041893Intralase FS LaserIntra Lase Corp. · 2005 · 3 generations on60descendants
- K060372Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006 · 4 generations on58descendants
- K063682Intralase Fusion LaserIntra Lase Corp. · 2007 · 5 generations on57descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954058 | Barraquer-Krumeich Refractive Set | Eyetech M.V.A. | 1995 | — |
| +1 | K980675 | Summit Krumeich-Barraquer Microkeratome | Summit Technology, Inc. | 1998 | 1 |
| +2 | K013151 | Asmotom Automated Trephine System | Bkg Opthalmics USA, Inc. | 2001 | — |
| +3 | K041893 | Intralase FS Laser | Intra Lase Corp. | 2005 | — |
| +4 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| +5 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 | 6 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (63)
See all 631 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980675 | Summit Krumeich-Barraquer Microkeratome | 1998 | 62 |
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, K980675 (Summit Technology, Inc., 1998) has gone furthest, with 62 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/K954058 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954058: 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/K954058
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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