Cleared Traditional

K994008 - BIOSYS FETAL MONITOR, MODEL IFM-500

K994008 is an FDA 510(k) clearance for BIOSYS FETAL MONITOR, manufactured by Biosys Co. , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K994008 · Biosys Co. , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
310d
Days
Class 2
Risk

K994008 is an FDA 510(k) clearance for the BIOSYS FETAL MONITOR, MODEL IFM-500. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Biosys Co. , Ltd. (San Leandro, US). The FDA issued a Cleared decision on September 29, 2000 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K994008

510(k) Number K994008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date September 29, 2000
Days to Decision 310 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
149d slower than avg
Panel avg: 161d · This submission: 310d
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 K994008.
SONICAID FM820, SONICAID FM830
K002150 · Oxford Instruments · Mar 2001
FETAL ASSIST
K002548 · Huntleigh Diagnostics , Ltd. · Mar 2001
FETALGARD LITE
K002503 · Analogic Corp. · Nov 2000
BABY DOPPLEX 4002-TWINS, MODEL BD4002
K001882 · Huntleigh Healthcare, Inc. · Sep 2000
BABY DOPPLEX 4000 (BD4000)
K001677 · Huntleigh Diagnostics , Ltd. · Aug 2000
COROMETRICS MODEL 173 FETAL MONITOR
K993751 · Ge Medical Systems Information Technologies · Feb 2000
K994008 · BIOSYS FETAL MONITOR, MODEL IFM-500
Download PDF FDA Summary Biosys Co. , Ltd.