# K131145: Proinsert

- Pathway: 510(k) (Traditional)
- Applicant: Nidacon International AB
- Decided: Feb 20, 2014 after 303 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
ProlnsertTh is used during preparation of human sperm from a semen sample using density gradient separation during assisted reproductive procedures. ProlnsertTm facilitates density gradient preparation and pellet retrieval following density gradient separation.

Source page: https://510kreport.com/device/K131145
Methodology: https://510kreport.com/methodology