# K881967: Cmi Vacuum Pump #001C - Vacuum Pump (Non-Electri.)

- Pathway: 510(k) (Traditional)
- Applicant: Challenge Mfg., Inc.
- Decided: Jun 13, 1988 after 33 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K981260: Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M (1998), 2 descendants of its own
- K250298: Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) (2025), 0 descendants of its own
- K043614: Vaculink, Model VCL 3000 (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K881967
Methodology: https://510kreport.com/methodology