# K981260: Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, Inc.
- Decided: Sep 22, 1998 after 169 days
- Product code: HDB (Extractor, Vacuum, Fetal)
- Device class: 2
- Regulation: 21 CFR 884.4340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890307 (1989). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890307: Mityvac M Style Vacuum Extractor, Disposable, Neward Enterprises, Inc. (1989) Summary page 1.
- K943938: Mityvac Super M Style Vacum Extractor, Disposable, Neward Enterprises, Inc. (1995). Our OCR of the scanned summary read K943928, FDA’s number for Apilus Electropil (Dectro Intl., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Mityvac Super “M” Style vacuum extractor”.
- K934011: Mityvac (R) Obstetric Vac Deliv Kit W/Univ Vac Release, Neward Enterprises, Inc. (1994) Summary page 1.
- K942725: Cmi Velvet Touch Vacuum Extractor, Columbia Medical & Surgical, Inc. (1995) Summary page 1.
- K881967: Cmi Vacuum Pump #001C - Vacuum Pump (Non-Electri.), Challenge Mfg., Inc. (1988) Summary page 1.
- K970170: Swift Delivery Product #002-Vac EX Cup W/Vac Rel Valve, Richard G. Lindsay (1997) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Mar 9, 2026 · Class II · Z-1945-2026: Due to complaints of device breakage at the traction force gauge to handle joint.
- Aug 6, 2019 · Class II · Z-2072-2020: There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.

## Indications for use
Standard vacuum extraction Use for fetal vacuum extraction in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions. Trial of vacuum extraction Vacuum delivery should be regarded as a “trial” 1) if there is arrest of descent in the second stage and fetopelvic relationships are considered to be boderline, or 2) in a mid-pelvic extraction when position and station are known. Vacuum extraction should be abandoned and birth completed by cesarean section 1) if no descent (progress) of the head occurs after 2 tractions, 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches (“pops-off”) twice.

Source page: https://510kreport.com/device/K981260
Methodology: https://510kreport.com/methodology