Cleared Traditional

K963287 - VACUUM CUP (004SD)

K963287 is an FDA 510(k) clearance for VACUUM CUP (004SD), manufactured by Swift Delivery Products. The device is a Class 2 Obstetrics & Gynecology device with product code HDB cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K963287 · Swift Delivery Products · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
68d
Days
Class 2
Risk

K963287 is an FDA 510(k) clearance for the VACUUM CUP (004SD). Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Swift Delivery Products (Oklahoma City, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 68 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 Swift Delivery Products devices

FDA 510(k) Submission Details - K963287

510(k) Number K963287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1996
Decision Date October 28, 1996
Days to Decision 68 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
92d faster than avg
Panel avg: 160d · This submission: 68d
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 10
Devices cleared under the same product code (HDB) and FDA review panel - the closest regulatory comparables to K963287.
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K980976 · Hollister, Inc. · Aug 1998
SWIFT DELIVERY PRODUCT #300
K973942 · Swift Delivery Products · Dec 1997
SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE
K970170 · Richard G. Lindsay · Mar 1997
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