# K020447: Mityvac Merlin, Model 10027

- Pathway: 510(k) (Special)
- Applicant: Prism Enterprises, Inc.
- Decided: Apr 12, 2002 after 60 days
- Product code: HDB (Extractor, Vacuum, Fetal)
- Device class: 2
- Regulation: 21 CFR 884.4340
- 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 K011532 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011532: Mityvac, Prism Enterprises, Inc. (2001) Summary page 2.

## Indications for use
Prism Enterprises, Inc.'s Mityvac® Merlin™ is intended to be utilized to assist a clinician in the delivery of an infant during childbirth. This device is indicated for use during vaginal delivery and Cesarean sections.

Source page: https://510kreport.com/device/K020447
Methodology: https://510kreport.com/methodology