Cleared Traditional

K973942 - SWIFT DELIVERY PRODUCT #300

K973942 is an FDA 510(k) clearance for SWIFT DELIVERY PRODUCT #300, 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 77-day FDA review.

K973942 · Swift Delivery Products · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
77d
Days
Class 2
Risk

K973942 is an FDA 510(k) clearance for the SWIFT DELIVERY PRODUCT #300. 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 December 12, 1997 after a review of 77 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 - K973942

510(k) Number K973942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1997
Decision Date December 12, 1997
Days to Decision 77 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 160d · This submission: 77d
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 9
Devices cleared under the same product code (HDB) and FDA review panel - the closest regulatory comparables to K973942.
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K895700 · Hollister, Inc. · Apr 1990