# K011607: Spermcatch

- Pathway: 510(k) (Traditional)
- Applicant: Nidacon International AB
- Decided: Aug 10, 2001 after 78 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991343 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991391: PVP, Polyvinylpyrrolidone 10% (W/V) in Hepes-HTF, Advanced Reproductive Technologies (2000) Summary page 1.
- K991343: PVP (Polyvinylpyrrolidone), Irvine Scientific Sales Co., Inc. (1999) Summary page 1.
- K001967: PVP-Polyvinylpyrrolidone Reagent, Model Cat#2210, Invitrocare, Inc. (2000) Summary page 1.

## Most influential descendants
- K052457: Picsi Sperm Selection Device (2006), 0 descendants of its own

## Indications for use
SpermCatch™ is a medium designed to modulate sperm motility in a physiological manner, to facilitate injecting a single spermatozoa into an oocyte (ICSI). ICSI is an available procedure in Assisted Reproduction Technology (ART).

Source page: https://510kreport.com/device/K011607
Methodology: https://510kreport.com/methodology