510(k) · Cleared
ClearedSeaforia Sperm Separation Assistance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lotus Bio, Ltd. · MQK Labware, Assisted Reproduction
Cleared on Dec 19, 2012 as substantially equivalent to K112413 (Research Instruments, Ltd., 2012) and 1 other predicate after a 464-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Dec 19, 2012
- Review
- 464 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K990941 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK990941 Newlife Dish (Etched or Non-Etched, with or Without Lid), Models…Humagen Fertility Diagnostics, Inc. · 1999
- 2 generations backK090429 Nunc Ivf Centerwell and Icsi DishesThermo Fisher Scientific (Nalge Nunc Intl) · 2009
- 1 generation backK112413 RI MSC (Migration Sedimentation Chamber)Research Instruments, Ltd. · 2012
- This deviceK112644 Seaforia Sperm Separation Assistance SystemLotus Bio, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990941 | Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E… | Humagen Fertility Diagnostics, Inc. | 1999 | — |
| −2 | K090429 | Nunc Ivf Centerwell and Icsi Dishes | Thermo Fisher Scientific (Nalge Nunc Intl) | 2009 | — |
| −1 | K112413 | RI MSC (Migration Sedimentation Chamber) | Research Instruments, Ltd. | 2012 | — |
| 0 (this device) | K112644 | Seaforia Sperm Separation Assistance System | Lotus Bio, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 MQK? 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 MQK device
- #1 K241626 SperSort™ Sperm Sorting Chip (IPG02)score 10.1 · 5 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 |
|---|---|---|---|
| * | K112413 | RI MSC (Migration Sedimentation Chamber) Cleared while this submission was under review Summary page 2…Pagel1of 8 Legally Marketed Device - Claiming Equivalence: RI Migration Sedimentation Chamber (MSC) Research Instruments Ltd K 112413 MTG- Minitfib Heated Stage System Zander Medical Supplies, Inc. K002971 Summary Description of the Device: The SeaforiaTrM Spe… | 2012 |
| * | K002971 | MTG - Minitub Heated Stage SystemsSummary page 2…vice - Claiming Equivalence: RI Migration Sedimentation Chamber (MSC) Research Instruments Ltd K 112413 MTG- Minitfib Heated Stage System Zander Medical Supplies, Inc. K002971 Summary Description of the Device: The SeaforiaTrM Sperm Separation Assistance System separates motile/progressively motile spe… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K112413.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MQK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQK
259in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQK
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQK
1in 2025
MAUDE reports naming product code MQK, 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 | 1 | — | 1 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 3 | 454 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 6 | 270 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 4 | 154 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 4 | 163 | 0 | 0 |
| 2025 | 3 | 259 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SeaforiaTM Sperm Separation Assistance System consists of the following components: The SeaforiaTM Sperm Separation Assistance System Disposable Kit (Versions 0.5-2 ml, 2.5-3.0 ml, 3.5-4.0 ml, 4.5-5.0 ml, and 5.5-6.0 ml) The SeaforiaTM Sperm Separation Assistance System Disposable Kit is intended for preparing motile sperm using the swim-up (SU) separation method and holding sperm for use in assisted reproductive procedures such as intrauterine…
Read the full statement (134 words)
The SeaforiaTM Sperm Separation Assistance System consists of the following components:
The SeaforiaTM Sperm Separation Assistance System Disposable Kit (Versions 0.5-2 ml, 2.5-3.0 ml, 3.5-4.0 ml, 4.5-5.0 ml, and 5.5-6.0 ml)
The SeaforiaTM Sperm Separation Assistance System Disposable Kit is intended for preparing motile sperm using the swim-up (SU) separation method and holding sperm for use in assisted reproductive procedures such as intrauterine insemination (IUI), intra-cervical insemination (ICI) and in-vitro fertilization (IVF). The SeaforiaTM Sperm Separation Assistance System Disposable Kit is indicated for incubation periods not exceeding one (1) hour.
The SeaforiaTM Sperm Separation Assistance System Heating Device
The SeaforiaTM Sperm Separation Assistance System Heating Device is indicated for use only with the SeaforiaTM Sperm Separation Assistance System Disposable Kit to maintain the temperature (37°C ±0.5) of sperm during the swim-up (SU) separation procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112644 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112644: Seaforia Sperm Separation Assistance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112644
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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