510(k) · Cleared
ClearedSaturn 5 Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Research Instruments, Ltd. · MRX System, Assisted Reproduction Laser
Cleared on Feb 18, 2015 as substantially equivalent to K083208 (Research Instruments, Ltd., 2009) and 1 other predicate after a 264-day review. Its family tree reaches back 3 generations to 2005. 3 later devices descend from it.
- Decided
- Feb 18, 2015
- Review
- 264 days
- Class
- Class II
- Product code
- MRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K050768 (2005). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK050768 Zilos-TK, Version 3, Zilos-TK, Version 4Hamilton Thorne Biosciences · 2005
- 2 generations backK060764 Saturn 3 Laser SystemResearch Instruments, Ltd. · 2007
- 1 generation backK083208 Saturn Active Laser SystemResearch Instruments, Ltd. · 2009
- This deviceK141434 Saturn 5 LaserResearch Instruments, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK253333 Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK202241 LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)Hamilton Thorne, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK192008 LaserShot M, NaviLaseVitrolife GmbH · 2020
Most influential descendants
Showing 3 of 3 · See all- K253333Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K202241LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)Hamilton Thorne, Inc. · 2021 · cites it directly0descendants
- K192008LaserShot M, NaviLaseVitrolife GmbH · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050768 | Zilos-TK, Version 3, Zilos-TK, Version 4 | Hamilton Thorne Biosciences | 2005 | — |
| −2 | K060764 | Saturn 3 Laser System | Research Instruments, Ltd. | 2007 | — |
| −1 | K083208 | Saturn Active Laser System | Research Instruments, Ltd. | 2009 | — |
| 0 (this device) | K141434 | Saturn 5 Laser | Research Instruments, Ltd. | 2015 | — |
| +1 | K253333 | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | 2026 | — |
| +1 | K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | Hamilton Thorne, Inc. | 2021 | — |
| +1 | K192008 | LaserShot M, NaviLase | Vitrolife GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K083208 | Saturn Active Laser SystemSummary page 4…ame: Laser, Assisted Reproduction (21CFR 884.6200) Regulatory Class: II Product Code: MRX Predicate Device Saturn 3 Laser Systems, K083208 and K060764 This predicate has not been subject to a design related recall. Description of the device The Saturn 5 is the lates… | 2009 |
| * | K060764 | Saturn 3 Laser SystemSummary page 4…Laser, Assisted Reproduction (21CFR 884.6200) Regulatory Class: II Product Code: MRX Predicate Device Saturn 3 Laser Systems, K083208 and K060764 This predicate has not been subject to a design related recall. Description of the device The Saturn 5 is the latest generation… | 2007 |
What descends from it? (3)
3 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 10 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K253333 (Hua Yue Medical Technology Co., Ltd., 2026) 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. 2015, 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?
For use in assisted reproduction procedures to ablate or thin the zona pellucida of an oocyte or embryo to facilitate assisted hatching or recovery of cells for pre-implantation genetic diagnosis (blastomeres). The device can also be used
on blastocyst stage embryos for biopsy of trophectoderm cells for pre-implantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141434: Saturn 5 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141434
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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