Cleared Traditional

K894646 - #556 DISPOSABLE UMBILICAL CORD CLAMP (2)

K894646 is the FDA 510(k) clearance for #556 DISPOSABLE UMBILICAL CORD CLAMP (2) by Alpha Unlimited, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HFW) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K894646 · Alpha Unlimited, Inc. · Obstetrics & Gynecology device
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Sep 1989
Decision
43d
Days
Class 2
Risk

K894646 is an FDA 510(k) clearance for the #556 DISPOSABLE UMBILICAL CORD CLAMP (2). Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Alpha Unlimited, Inc. (Clearwater, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 43 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 Alpha Unlimited, Inc. devices

Submission Details

510(k) Number K894646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date September 05, 1989
Days to Decision 43 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 160d · This submission: 43d
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

All 8
Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K894646.
UMBICUT
K000227 · Pollak (Intl.), Ltd. · Apr 2000
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