Cleared Special

OB-1 FETAL MONITOR (K011304) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011304 · Analogic Corp. · Obstetrics & Gynecology device
Download Printable Device Report (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.

View all Analogic Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 160d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 25
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K011304.
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express
K173042 · Edan Instruments, Inc. · Aug 2018
AlertWatch:OB
K173715 · Alertwatch, Inc. · Apr 2018
Central Monitoring System
K171178 · Edan Instruments, Inc. · Sep 2017
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
K942887 · Hewlett-Packard Co. · Aug 1994
HEWLETT PACKARD MODEL M1353A FETAL MONITOR
K921956 · Hewlett-Packard Co. · Sep 1993
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
K921957 · Hewlett-Packard Co. · Sep 1993