Cleared Traditional

K002548 - FETAL ASSIST

K002548 is an FDA 510(k) clearance for FETAL ASSIST, manufactured by Huntleigh Diagnostics , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K002548 · Huntleigh Diagnostics , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
201d
Days
Class 2
Risk

K002548 is an FDA 510(k) clearance for the FETAL ASSIST. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Huntleigh Diagnostics , Ltd. (Cardiff Wales, GB). The FDA issued a Cleared decision on March 6, 2001 after a review of 201 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - 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.

FDA 510(k) Submission Details - K002548

510(k) Number K002548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date March 06, 2001
Days to Decision 201 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 161d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
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 - HGM System, Monitoring, Perinatal

All 214
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K002548.
BABY DOPPLEX 3000 MK 2 (BD3000)
K010889 · Huntleigh Healthcare, Inc. · Apr 2001
BABY DOPPLEX 3002 (BD3002)
K010894 · Huntleigh Healthcare, Inc. · Apr 2001
SONICAID FM820, SONICAID FM830
K002150 · Oxford Instruments · Mar 2001
FETALGARD LITE
K002503 · Analogic Corp. · Nov 2000
BIOSYS FETAL MONITOR, MODEL IFM-500
K994008 · Biosys Co. , Ltd. · Sep 2000
BABY DOPPLEX 4002-TWINS, MODEL BD4002
K001882 · Huntleigh Healthcare, Inc. · Sep 2000
K002548 · FETAL ASSIST
Download PDF FDA Summary Huntleigh Diagnostics…