Cleared Traditional

K901954 - AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEV...

K901954 is an FDA 510(k) clearance for AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEV..., manufactured by Hollister, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K901954 · Hollister, Inc. · Obstetrics & Gynecology device
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Jul 1990
Decision
86d
Days
Class 2
Risk

K901954 is an FDA 510(k) clearance for the AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Hollister, Inc. (Chicago, US). The FDA issued a Cleared decision on July 26, 1990 after a review of 86 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K901954

510(k) Number K901954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date July 26, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 160d · This submission: 86d
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 8
Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K901954.
UMBICUT
K000227 · Pollak (Intl.), Ltd. · Apr 2000
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
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