510(k) · Cleared
ClearedAsmotom Automated Trephine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bkg Opthalmics USA, Inc. · HRG Engine, Trephine, Accessories, Ac-Powered
Cleared on Dec 14, 2001 as substantially equivalent to K980675 (Summit Technology, Inc., 1998) after an 85-day review. Its family tree reaches back 2 generations to 1995. 61 later devices descend from it.
- Decided
- Dec 14, 2001
- Review
- 85 days
- Class
- Class I
- Product code
- HRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954058 (1995). 61 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK954058 Barraquer-Krumeich Refractive SetEyetech M.V.A. · 1995
- 1 generation backK980675 Summit Krumeich-Barraquer MicrokeratomeSummit Technology, Inc. · 1998 · Recalled
- This deviceK013151 Asmotom Automated Trephine SystemBkg Opthalmics USA, Inc. · 2001
- Descendant · cites it directly · 60 of its ownK041893 Intralase FS LaserIntra Lase Corp. · 2005
- Descendant · 2 generations on · 58 of its ownK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- Descendant · 3 generations on · 57 of its ownK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- Descendant · 3 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- Descendant · 2 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K041893Intralase FS LaserIntra Lase Corp. · 2005 · cites it directly60descendants
- K060372Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006 · 2 generations on58descendants
- K063682Intralase Fusion LaserIntra Lase Corp. · 2007 · 3 generations on57descendants
- K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 3 generations on56descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 2 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954058 | Barraquer-Krumeich Refractive Set | Eyetech M.V.A. | 1995 | — |
| −1 | K980675 | Summit Krumeich-Barraquer Microkeratome | Summit Technology, Inc. | 1998 | 1 |
| 0 (this device) | K013151 | Asmotom Automated Trephine System | Bkg Opthalmics USA, Inc. | 2001 | — |
| +1 | K041893 | Intralase FS Laser | Intra Lase Corp. | 2005 | — |
| +2 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| +3 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| +3 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| +2 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HRG? 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 |
|---|---|---|---|
| * | K980675 | Summit Krumeich-Barraquer MicrokeratomeSummary page 1…Automated Trephine System Classification Name: Trephine, AC-Powered Product Code: HRG Regulation Number: 886.4070 Predicate Device: Summit Technology K-B Microkeratome ~ K980675 Intended Use: The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea… | 1998 |
What descends from it? (61)
See all 612 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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K041893 (Intra Lase Corp., 2005) has gone furthest, with 60 descendants of its own.
How does its category compare?
All HRG devicesHRG Engine, Trephine, Accessories, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRG
FDA has decided no HRG device since 2007.
Median 510(k) review, days · HRG
Too few HRG 510(k)s in any year since 2007 to give a median.
Recalls per year · HRG
No recall names HRG since 2007.
Adverse event reports per year · HRG
1in 2025
MAUDE reports naming product code HRG, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea. The purpose of this device is to produce cuts necessary for the corneal transplantation.
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/K013151 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013151: Asmotom Automated Trephine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013151
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026