510(k) · Cleared
ClearedZilos-TK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Thorne Biosciences · MRX System, Assisted Reproduction Laser
Cleared on Apr 24, 2007 after a 138-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Apr 24, 2007
- Review
- 138 days
- Class
- Class II
- Product code
- MRX
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK063636 Zilos-TKHamilton Thorne Biosciences · 2007
- Descendant · cites it directly · 0 of its ownK120055 Hanilton Thorne Infrared Laser Optical System-Zilos-TK Hamilton…Hamilton Thorne, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120055Hanilton Thorne Infrared Laser Optical System-Zilos-TK Hamilton Thorne Infrared Laser…Hamilton Thorne, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063636 | Zilos-TK | Hamilton Thorne Biosciences | 2007 | — |
| +1 | K120055 | Hanilton Thorne Infrared Laser Optical System-Zilos-TK Hamilton Thorne… | Hamilton Thorne, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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 MRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRX device
- #1 K253333 Assisted Reproduction Laser System (Model…score 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K040451 | FDA’s K040451 is Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896 Our reading of the summary gave K040451, FDA’s number for Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848… (Pharmacia Deutschland GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “ZILOS-tk”. Kept off the family tree. | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120055 | Hanilton Thorne Infrared Laser Optical System-Zilos-TK Hamilton Thorne Infrared Laser… | 2012 | 0 |
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, K120055 (Hamilton Thorne, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MRX devicesMRX System, Assisted Reproduction Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MRX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MRX
Too few MRX 510(k)s in any year since 2007 to give a median.
Recalls per year · MRX
No recall names MRX since 2007.
Adverse event reports per year · MRX
No MAUDE report names MRX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This system is intended to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as advanced maternal age, prior failed IVF procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in IVF patients undergoing PGD to avoid genetic disease or aneuploidy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063636: Zilos-TK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063636
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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