Cleared Traditional

K974227 - HOSPITAL'S CLAMP

K974227 is an FDA 510(k) clearance for HOSPITAL'S CLAMP, manufactured by Gps. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K974227 · Gps · Obstetrics & Gynecology device
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Dec 1997
Decision
30d
Days
Class 2
Risk

K974227 is an FDA 510(k) clearance for the HOSPITAL'S CLAMP. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Gps (Port Washington, US). The FDA issued a Cleared decision on December 12, 1997 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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.

FDA 510(k) Submission Details - K974227

510(k) Number K974227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date December 12, 1997
Days to Decision 30 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
131d faster than avg
Panel avg: 161d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFW Device Classification - Class 2, Special Controls

Product Code HFW Clamp, Umbilical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HFW Clamp, Umbilical

All 35
Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K974227.
SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
K994263 · Precision Dynamics Corp. · Jan 2000
'ECURLINE UMBILICAL CORD CLAMP #3500
K990737 · Precision Dynamics Corp. · Apr 1999
HARWILL MEDICAL U-KLIP UMBILICAL CLAMP
K983204 · Harwill Medical (Pty) , Ltd. · Feb 1999
EZ-CIRC
K963223 · Phyllis Adams, Rn, Npc, Msn · Apr 1997
QFC UMBILICAL CLAMP
K963889 · Qfc Industries · Apr 1997
UMBILICAL CLAMP AND CUTTER
K963428 · R.O.S.T. Medical Development, Inc. · Apr 1997
K974227 · HOSPITAL'S CLAMP
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