Cleared Traditional

K981260 - KIWI SOFT CUP WITH PALM PUMP MODEL NUMB...

K981260 is an FDA 510(k) clearance for KIWI SOFT CUP WITH PALM PUMP MODEL NUMB..., manufactured by Clinical Innovations, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDB cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K981260 · Clinical Innovations, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
169d
Days
Class 2
Risk

K981260 is an FDA 510(k) clearance for the KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH P.... Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Clinical Innovations, Inc. (Murray, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 169 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4340 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Innovations, Inc. devices

FDA 510(k) Submission Details - K981260

510(k) Number K981260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1998
Decision Date September 22, 1998
Days to Decision 169 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 160d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDB Device Classification - Class 2, Special Controls

Product Code HDB Extractor, Vacuum, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HDB Extractor, Vacuum, Fetal

Devices cleared under the same product code (HDB) and FDA review panel - the closest regulatory comparables to K981260.
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M)
K250298 · Clinical Innovations, LLC · Oct 2025
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
K041579 · Medela AG · Apr 2005
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K980976 · Hollister, Inc. · Aug 1998
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
K895700 · Hollister, Inc. · Apr 1990
SILASTIC BRAND OBSTETRICAL VACUUM CUP
K771558 · Dow Corning Corp. Healthcare Industries Materials · Sep 1977