Cleared Traditional

K854267 - HUNTLEIGH DOPCORD

K854267 is an FDA 510(k) clearance for HUNTLEIGH DOPCORD, manufactured by Huntleigh Technology, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K854267 · Huntleigh Technology, Inc. · Obstetrics & Gynecology device
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Jul 1986
Decision
259d
Days
Class 2
Risk

K854267 is an FDA 510(k) clearance for the HUNTLEIGH DOPCORD, D140. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Huntleigh Technology, Inc. (Manalapan, US). The FDA issued a Cleared decision on July 9, 1986 after a review of 259 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - 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 Huntleigh Technology, Inc. devices

FDA 510(k) Submission Details - K854267

510(k) Number K854267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1985
Decision Date July 09, 1986
Days to Decision 259 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 slower than avg
Panel avg: 160d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNG Device Classification - Class 2, Special Controls

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 - KNG Monitor, Ultrasonic, Fetal

All 23
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K854267.
SONOTRAX ULTRASONIC POCKET DOPPLER
K040480 · Edan Instruments, Inc. · May 2004
UST-974-5 CONVEX TRANSDUCER
K910153 · Ge Medical Systems Information Technologies · Mar 1991
HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
K900618 · Huntleigh Technology, Inc. · Apr 1990
PROGRAMALITH PROGRAMMER
K823242 · Pacesetter Systems · Jan 1983
DOPPLEX-PLB & PXB
K810115 · Huntleigh Technology, Inc. · Jul 1981