Cleared Traditional

K020718 - SECURLINE UMBILICAL CORD CLAMP #3505 ST...

K020718 is the FDA 510(k) clearance for SECURLINE UMBILICAL CORD CLAMP #3505 ST... by Precision Dynamics Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HFW) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020718 · Precision Dynamics Corp. · Obstetrics & Gynecology device
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Jun 2002
Decision
90d
Days
Class 2
Risk

K020718 is an FDA 510(k) clearance for the SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Precision Dynamics Corp. (San Fernando, US). The FDA issued a Cleared decision on June 3, 2002 after a review of 90 days - within the typical 510(k) review window.

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: 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.

View all Precision Dynamics Corp. devices

Submission Details

510(k) Number K020718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2002
Decision Date June 03, 2002
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K020718.
AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER
K934525 · United States Surgical, A Division of Tyco Healthc · Feb 1994
AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC
K901954 · Hollister, Inc. · Jul 1990
COMPRESSION FORCEPS
K890382 · Kinetic Medical Products · Feb 1989
UMBILICAL CORD CLAMP
K880753 · I M, Inc. · Apr 1988
UMBILICAL CORD CLAMP
K781548 · Hollister, Inc. · Oct 1978