Cleared Traditional

K980976 - AMEDA DISPOSABLE VACUUM ASSIST CUP WITH...

K980976 is an FDA 510(k) clearance for AMEDA DISPOSABLE VACUUM ASSIST CUP WITH..., manufactured by Hollister, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDB cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K980976 · Hollister, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
158d
Days
Class 2
Risk

K980976 is an FDA 510(k) clearance for the AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP. Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on August 21, 1998 after a review of 158 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K980976

510(k) Number K980976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1998
Decision Date August 21, 1998
Days to Decision 158 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 160d · This submission: 158d
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 K980976.
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/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