# K991229: K-Systems Work Stations, Type L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L

- Pathway: 510(k) (Traditional)
- Applicant: Henning Knudsen Engineering A/S
- Decided: Jun 29, 1999 after 78 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The K~-SYSTEMS Work Station is intended for maintaining temperature of gametes and/or embryos at or near body temperature. The work station also includes features to humidify and maintain a constant pH environment for the gametes and/or embryos. Additionally the work station is flushed with steritenair.

Source page: https://510kreport.com/device/K991229
Methodology: https://510kreport.com/methodology