# K112644: Seaforia Sperm Separation Assistance System

- Pathway: 510(k) (Traditional)
- Applicant: Lotus Bio, Ltd.
- Decided: Dec 19, 2012 after 464 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990941 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112413: RI MSC (Migration Sedimentation Chamber), Research Instruments, Ltd. (2012). Cleared while this submission was under review Summary page 2.
- K002971: MTG - Minitub Heated Stage Systems, Zander Medical Supplies, Inc. (2000) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K112644
Methodology: https://510kreport.com/methodology