Cleared Traditional

K880753 - UMBILICAL CORD CLAMP

K880753 is an FDA 510(k) clearance for UMBILICAL CORD CLAMP, manufactured by I M, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K880753 · I M, Inc. · Obstetrics & Gynecology device
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Apr 1988
Decision
62d
Days
Class 2
Risk

K880753 is an FDA 510(k) clearance for the UMBILICAL CORD CLAMP. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by I M, Inc. (Fairfield, US). The FDA issued a Cleared decision on April 27, 1988 after a review of 62 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.

FDA 510(k) Submission Details - K880753

510(k) Number K880753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1988
Decision Date April 27, 1988
Days to Decision 62 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
99d faster than avg
Panel avg: 161d · This submission: 62d
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 35
Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K880753.
UMBILICAL CORD CLAMP AND CUTTER
K901557 · Microtek-Heritage, Inc. · May 1990
#556 DISPOSABLE UMBILICAL CORD CLAMP (2)
K894646 · Alpha Unlimited, Inc. · Sep 1989
COMPRESSION FORCEPS
K890382 · Kinetic Medical Products · Feb 1989
SCMT UMBILICAL CLAMP
K871075 · Salt Creek Medical Technologies · Mar 1987
DOLPHIN UMBILICAL CORD CLAMP
K870446 · Andermac, Inc. · Feb 1987
SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000
K863645 · United Medical Systems, Inc. · Sep 1986
K880753 · UMBILICAL CORD CLAMP
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