Cleared Traditional

K891465 - OBSTETRIC CUP (MODIFICATION)

K891465 is an FDA 510(k) clearance for OBSTETRIC CUP (MODIFICATION), 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 57-day FDA review.

K891465 · Go Medical Industries Pty. , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
57d
Days
Class 2
Risk

K891465 is an FDA 510(k) clearance for the OBSTETRIC CUP (MODIFICATION). Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Go Medical Industries Pty. , Ltd. (Subiaco, Perth, AU). The FDA issued a Cleared decision on May 11, 1989 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Go Medical Industries Pty. , Ltd. devices

FDA 510(k) Submission Details - K891465

510(k) Number K891465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1989
Decision Date May 11, 1989
Days to Decision 57 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
103d faster than avg
Panel avg: 160d · This submission: 57d
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 K891465.
MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE
K960549 · Neward Enterprises, Inc. · Aug 1996
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