KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M— 510(k) K981260
Substantially EquivalentClinical Innovations, Inc.
FDA 510(k) clearance K981260 for KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M, Substantially Equivalent on 1998-09-22. Applicant: Clinical Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Innovations, Inc.
- Product code
- Code HDB
- Device class
- Class 2
- Regulation
- 21 CFR 884.4340
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murray, UT, US
Recent devices under product code HDB
view allMore clearances from Clinical Innovations, Inc.
view all- K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000
- K022023 — COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
- K003458 — SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
- K974563 — COLPO CUP CVC-2000
- K974389 — KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
Adverse events under product code HDB
product code HDB- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K981260
K-number listed on FDA's recall record- Z-1945-2026 — Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
- Z-2072-2020 — Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981260.
Data sourced from openFDA. This site is unofficial and independent of the FDA.