Cleared Traditional

K912054 - LABOR DELIVERY TRAY

K912054 is an FDA 510(k) clearance for LABOR DELIVERY TRAY, manufactured by Medical Device Inspection Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K912054 · Medical Device Inspection Co., Inc. · Obstetrics & Gynecology device
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Jan 1992
Decision
257d
Days
Class 2
Risk

K912054 is an FDA 510(k) clearance for the LABOR DELIVERY TRAY. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on January 21, 1992 after a review of 257 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 Medical Device Inspection Co., Inc. devices

FDA 510(k) Submission Details - K912054

510(k) Number K912054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 09, 1991
Decision Date January 21, 1992
Days to Decision 257 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
97d slower than avg
Panel avg: 160d · This submission: 257d
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 K912054.
QFC UMBILICAL CLAMP
K963889 · Qfc Industries · Apr 1997
UMBILICAL CLAMP AND CUTTER
K963428 · R.O.S.T. Medical Development, Inc. · Apr 1997
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