# K011532: Mityvac

- Pathway: 510(k) (Special)
- Applicant: Prism Enterprises, Inc.
- Decided: Jul 30, 2001 after 73 days
- Product code: HDB (Extractor, Vacuum, Fetal)
- Device class: 2
- Regulation: 21 CFR 884.4340
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043614: Vaculink, Model VCL 3000 (2005), 0 descendants of its own
- K020447: Mityvac Merlin, Model 10027 (2002), 0 descendants of its own

## Recalls of this device
- Jan 16, 2008 · Not classified · Z-1887-2008: Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for del
- Jan 16, 2008 · Not classified · Z-1888-2008: Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for del
- Jan 16, 2008 · Not classified · Z-1889-2008: Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for del
- Aug 17, 2004 · Not classified · Z-0005-05: Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System

Source page: https://510kreport.com/device/K011532
Methodology: https://510kreport.com/methodology