Cleared Traditional

K963428 - UMBILICAL CLAMP AND CUTTER

K963428 is an FDA 510(k) clearance for UMBILICAL CLAMP AND CUTTER, manufactured by R.O.S.T. Medical Development, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K963428 · R.O.S.T. Medical Development, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
214d
Days
Class 2
Risk

K963428 is an FDA 510(k) clearance for the UMBILICAL CLAMP AND CUTTER. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by R.O.S.T. Medical Development, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on April 1, 1997 after a review of 214 days - an extended review 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: 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 R.O.S.T. Medical Development, Inc. devices

FDA 510(k) Submission Details - K963428

510(k) Number K963428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1996
Decision Date April 01, 1997
Days to Decision 214 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
54d slower than avg
Panel avg: 160d · This submission: 214d
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 19
Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K963428.
HOSPITAL'S CLAMP
K974227 · Gps · Dec 1997
EZ-CIRC
K963223 · Phyllis Adams, Rn, Npc, Msn · Apr 1997
QFC UMBILICAL CLAMP
K963889 · Qfc Industries · 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