# K991341: Isolate, Isolate Concentrate, Isolate Stock Solution

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jul 8, 1999 after 80 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K872849 (1987). 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)
- K971809: Isolate, Irvine Scientific Sales Co., Inc. (1997) Summary page 3.

## Most influential descendants
- K023403: Spermgrad, Models 10022/10063 (2002), 0 descendants of its own

## Recalls of this device
- Nov 2, 2023 · Class II · Z-0998-2024: The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may c

## Indications for use
ISolate® is a density gradient medium designed to separate the motile fraction of sperm from seminal fluid. As a two-layer gradient system, it effectively reduces cellular contaminants such as dead sperm, white blood cells and miscellaneous debris. The resulting sample contains predeminantly motile sperm. It is intended for use as a human sperm separation medium, to concentrate and purify viable sperm, prior to in vitro fertilization, and related assisted reproductive technology, procedures.

Source page: https://510kreport.com/device/K991341
Methodology: https://510kreport.com/methodology