Cleared Traditional

K030261 - BATTERY, RECHARGEABLE

K030261 is an FDA 510(k) clearance for BATTERY, manufactured by Access Battery, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030261 · Access Battery, Inc. · Obstetrics & Gynecology device
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Apr 2003
Decision
90d
Days
Class 2
Risk

K030261 is an FDA 510(k) clearance for the BATTERY, RECHARGEABLE. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Access Battery, Inc. (Elizabeth, US). The FDA issued a Cleared decision on April 24, 2003 after a review of 90 days - within the typical 510(k) review window.

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 - K030261

510(k) Number K030261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2003
Decision Date April 24, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 161d · This submission: 90d
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 209
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K030261.
TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
K040819 · American I.V. Products, Inc. · Aug 2004
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
K032772 · Hill-Rom Manufacturing, Inc. · Oct 2003
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · Ge Medical Systems Information Technologies · Aug 2003
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
K023931 · Philips Medical Systems, Inc. · Feb 2003
SONICAID ONE
K023618 · Oxford Instruments Medical , Ltd. · Jan 2003
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
K021574 · Card Guard Scientific Survival , Ltd. · Aug 2002
K030261 · BATTERY, RECHARGEABLE
Download PDF Access Battery, Inc.