# K991216: Hoffman Ivf-1

- Pathway: 510(k) (Traditional)
- Applicant: (Arms) Hoffman Surgical Equipment, Ivf Division
- Decided: Aug 5, 1999 after 118 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
To maintain a temperature and pH in an enclosed device for oocyte screening, fertilization identification, cleavage check and embryo transfer.

Source page: https://510kreport.com/device/K991216
Methodology: https://510kreport.com/methodology