Cleared Traditional

K891465 - OBSTETRIC CUP (MODIFICATION)

K891465 is the FDA 510(k) clearance for OBSTETRIC CUP (MODIFICATION) by Go Medical Industries Pty. , Ltd.. It is a Class 2 Obstetrics & Gynecology device (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
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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

Submission Details

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.

Device Classification

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 K891465.
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