510(k) · Cleared
Recalled · 2002Summit Krumeich-Barraquer Microkeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Technology, Inc. · HNO Keratome, Ac-Powered
Cleared on Dec 22, 1998 as substantially equivalent to K954058 (Eyetech M.V.A., 1995) after a 305-day review. Its family tree reaches back 1 generation to 1995. 62 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 1998
- Review
- 305 days
- Class
- Class I
- Product code
- HNO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954058 (1995). 62 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK954058 Barraquer-Krumeich Refractive SetEyetech M.V.A. · 1995
- This deviceK980675 Summit Krumeich-Barraquer MicrokeratomeSummit Technology, Inc. · 1998
- Descendant · cites it directly · 61 of its ownK013151 Asmotom Automated Trephine SystemBkg Opthalmics USA, Inc. · 2001
- Descendant · 2 generations on · 60 of its ownK041893 Intralase FS LaserIntra Lase Corp. · 2005
- Descendant · 3 generations on · 58 of its ownK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- Descendant · 4 generations on · 57 of its ownK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- Descendant · 4 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K013151Asmotom Automated Trephine SystemBkg Opthalmics USA, Inc. · 2001 · cites it directly61descendants
- K041893Intralase FS LaserIntra Lase Corp. · 2005 · 2 generations on60descendants
- K060372Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006 · 3 generations on58descendants
- K063682Intralase Fusion LaserIntra Lase Corp. · 2007 · 4 generations on57descendants
- K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 4 generations on56descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954058 | Barraquer-Krumeich Refractive Set | Eyetech M.V.A. | 1995 | — |
| 0 (this device) | K980675 | Summit Krumeich-Barraquer Microkeratome | Summit Technology, Inc. | 1998 | — |
| +1 | K013151 | Asmotom Automated Trephine System | Bkg Opthalmics USA, Inc. | 2001 | — |
| +2 | K041893 | Intralase FS Laser | Intra Lase Corp. | 2005 | — |
| +3 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| +4 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| +4 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (1)
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 |
|---|---|---|---|
| * | K954058 | Barraquer-Krumeich Refractive SetSummary page 2…ppendix L. A\ Danger mdo Caution December 15, 1998 K9%06:75 6. Equivalent /Predicate Device: » Eyetech — Barraquer-Krumeich-Swinger Refractive Set, K954058 7. Device Description: The Summit Krumeich-Barraquer Microkeratome is an automated version of the Eyetech- Barraquer-Krumeich S… | 1995 |
What descends from it? (62)
See all 621 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013151 | Asmotom Automated Trephine System | 2001 | 61 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2002 | Not classified | Z-0612-03 | Other | Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K013151 (Bkg Opthalmics USA, Inc., 2001) has gone furthest, with 61 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 | — |
What is it indicated for?
Keratoplasty & corneal harvesting
Microlamellar keratoplasty
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/K980675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980675: Summit Krumeich-Barraquer Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980675
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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