Cleared Traditional

K901557 - UMBILICAL CORD CLAMP AND CUTTER

K901557 is an FDA 510(k) clearance for UMBILICAL CORD CLAMP AND CUTTER, manufactured by Microtek-Heritage, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K901557 · Microtek-Heritage, Inc. · Obstetrics & Gynecology device
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May 1990
Decision
42d
Days
Class 2
Risk

K901557 is an FDA 510(k) clearance for the UMBILICAL CORD CLAMP AND CUTTER. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Microtek-Heritage, Inc. (Tucker, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 42 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 Microtek-Heritage, Inc. devices

FDA 510(k) Submission Details - K901557

510(k) Number K901557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1990
Decision Date May 15, 1990
Days to Decision 42 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
118d faster than avg
Panel avg: 160d · This submission: 42d
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 K901557.
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
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