Cleared Special

K011304 - OB-1 FETAL MONITOR

K011304 is an FDA 510(k) clearance for OB-1 FETAL MONITOR, manufactured by Analogic Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Special 510(k) pathway after a 29-day FDA review.

K011304 · Analogic Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
29d
Days
Class 2
Risk

K011304 is an FDA 510(k) clearance for the OB-1 FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Analogic Corp. (Wakefield, US). The FDA issued a Cleared decision on May 29, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011304

510(k) Number K011304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2001
Decision Date May 29, 2001
Days to Decision 29 days
Submission Type Special
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
132d faster than avg
Panel avg: 161d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K011304.
VERSALAB APM
K013281 · Nicolet Biomedical · Apr 2002
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
K014094 · Hill-Rom Manufacturing, Inc. · Jan 2002
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · Ge Medical Systems Information Technologies · Nov 2001
CG-900P FETAL/MATERNAL MONITOR
K010552 · Card Guard Scientific Survival , Ltd. · May 2001
SONICAID SYSTEM 8002
K992607 · Oxford Instruments Medical Systems · Apr 2001
BABY DOPPLEX 3000 MK 2 (BD3000)
K010889 · Huntleigh Healthcare, Inc. · Apr 2001
K011304 · OB-1 FETAL MONITOR
Download PDF FDA Summary Analogic Corp.