Cleared Traditional

K994263 - SECURLINE UMBILICAL CORD CLAMP CLIPPER ...

K994263 is the FDA 510(k) clearance for SECURLINE UMBILICAL CORD CLAMP CLIPPER ... by Precision Dynamics Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HFW) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K994263 · Precision Dynamics Corp. · Obstetrics & Gynecology device
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Jan 2000
Decision
38d
Days
Class 2
Risk

K994263 is an FDA 510(k) clearance for the SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540. 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 January 24, 2000 after a review of 38 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.

View all Precision Dynamics Corp. devices

Submission Details

510(k) Number K994263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1999
Decision Date January 24, 2000
Days to Decision 38 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
122d faster than avg
Panel avg: 160d · This submission: 38d
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 K994263.
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