Cleared Traditional

K951140 - KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR

K951140 is an FDA 510(k) clearance for KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR, manufactured by Balagan Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K951140 · Balagan Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
73d
Days
Class 2
Risk

K951140 is an FDA 510(k) clearance for the KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Balagan Medical, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on May 25, 1995 after a review of 73 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 Balagan Medical, Inc. devices

FDA 510(k) Submission Details - K951140

510(k) Number K951140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date May 25, 1995
Days to Decision 73 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
87d faster than avg
Panel avg: 160d · This submission: 73d
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 20
Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K951140.
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
AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER
K934525 · United States Surgical, A Division of Tyco Healthc · Feb 1994
LABOR DELIVERY TRAY
K912054 · Medical Device Inspection Co., Inc. · Jan 1992
AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC
K901954 · Hollister, Inc. · Jul 1990