Cleared Traditional

K013460 - SWIFT LOW PROFILE CUP (PRO CUP)

K013460 is an FDA 510(k) clearance for SWIFT LOW PROFILE CUP (PRO CUP), 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 91-day FDA review.

K013460 · Swift Delivery Products · Obstetrics & Gynecology device
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Jan 2002
Decision
91d
Days
Class 2
Risk

K013460 is an FDA 510(k) clearance for the SWIFT LOW PROFILE CUP (PRO CUP). 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 January 17, 2002 after a review of 91 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.

FDA 510(k) Submission Details - K013460

510(k) Number K013460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2001
Decision Date January 17, 2002
Days to Decision 91 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 161d · This submission: 91d
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 29
Devices cleared under the same product code (HDB) and FDA review panel - the closest regulatory comparables to K013460.
VACULINK, MODEL VCL 3000
K043614 · Medevco, Inc. · Apr 2005
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
K021193 · Fortune Medical Instrument Corp. · Feb 2003
MITYVAC MERLIN, MODEL 10027
K020447 · Prism Enterprises, Inc. · Apr 2002
MITYVAC
K011532 · Prism Enterprises, Inc. · Jul 2001
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
K981260 · Clinical Innovations, Inc. · Sep 1998
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K980976 · Hollister, Inc. · Aug 1998
K013460 · SWIFT LOW PROFILE CUP (PRO CUP)
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