# K971809: Isolate

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jul 3, 1997 after 49 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 K872849 (1987). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872849: Sperm-Select Additional Indication, Pharmacia, Inc. (1987) Summary page 1.
- K894432: Modified Ham's F-10 W/Albumin, Irvine Scientific (1989) Summary page 1.

## Most influential descendants
- K991341: Isolate, Isolate Concentrate, Isolate Stock Solution (1999), 1 descendant of its own
- K980814: Puresperm (1998), 1 descendant of its own
- K023403: Spermgrad, Models 10022/10063 (2002), 0 descendants of its own
- K984172: Modification of Puresperm (1999), 0 descendants of its own

## Indications for use
The product is intended for use in the preparation of human sperm for intrauterine insemination (IUI).

Source page: https://510kreport.com/device/K971809
Methodology: https://510kreport.com/methodology