# K153267: ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Jul 22, 2016 after 253 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991332 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003404: Suprasperm System, Medicult A/S (2001) Summary page 4.
- K991332: Medi-Cult Sperm Preparation - Medium;, Medicult A/S (2000) Summary page 4.

## Most influential descendants
- K241833: V-GRAD (2025), 0 descendants of its own

## Recalls of this device
- Feb 16, 2024 · Class II · Z-3297-2024: Low concentration of sodium pyruvate in the wash could compromise gamete development
- Feb 16, 2024 · Class II · Z-3296-2024: Low concentration of sodium pyruvate in the wash could compromise gamete development
- Feb 16, 2024 · Class II · Z-3298-2024: Low concentration of sodium pyruvate in the wash could compromise gamete development

## Indications for use
ORIGIO® Sperm Wash is intended for washing of spermatozoa, the isolation of motile viable sperm by swim-up method, dilution of ORIGIO gradients, and holding sperm for IUI procedure ORIGIO® Gradient™ 100, ORIGIO® Gradient™ 90 and ORIGIO® Gradient™ 40/80 are for separation of motile sperm from the ejaculate by the density gradient method.

Source page: https://510kreport.com/device/K153267
Methodology: https://510kreport.com/methodology