Cleared Traditional

K840008 - O'NEIL OBSTETRIC CUP

K840008 is an FDA 510(k) clearance for O'NEIL OBSTETRIC CUP, manufactured by Go Medical Industries Pty. , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HDB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K840008 · Go Medical Industries Pty. , Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 1984
Decision
112d
Days
Class 2
Risk

K840008 is an FDA 510(k) clearance for the O'NEIL OBSTETRIC CUP. Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Go Medical Industries Pty. , Ltd. (Walker, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 112 days - within the typical 510(k) review window.

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 Go Medical Industries Pty. , Ltd. devices

FDA 510(k) Submission Details - K840008

510(k) Number K840008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1984
Decision Date April 25, 1984
Days to Decision 112 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 160d · This submission: 112d
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

All 15
Devices cleared under the same product code (HDB) and FDA review panel - the closest regulatory comparables to K840008.
OBSTETRICAL VACUUM CUP
K911326 · Gesco Intl., Inc. · Aug 1991
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
K895700 · Hollister, Inc. · Apr 1990
AB VACUUM EXTRACTOR SILC-CUP
K841492 · Medela, Inc. · May 1984
MEDELA SUCTION PUMP
K830012 · Medela, Inc. · Jan 1983
SILASTIC BRAND OBSTETRICAL VACUUM CUP
K771558 · Dow Corning Corp. Healthcare Industries Materials · Sep 1977