# K041952: Zivf-Aire

- Pathway: 510(k) (Traditional)
- Applicant: Zander Medical Supplies, Inc.
- Decided: Sep 8, 2005 after 415 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 zIVF-AIRe Photo Catalytic Air Purification System models IVF-F20C and IVF-100C are designed to improve indoor air quality. The manufacturer's models QA-20, SP-20, and SP-20C for residential and general office use were re-engineered for use in IVF laboratories, in Reproductive, Endocrinology, and Andrology laboratories, as well as for general hospital use.

Source page: https://510kreport.com/device/K041952
Methodology: https://510kreport.com/methodology