Cleared Special

K010889 - BABY DOPPLEX 3000 MK 2 (BD3000) (FDA 510(k) Clearance)

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

K010889 · Huntleigh Healthcare, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
30d
Days
Class 2
Risk

K010889 is an FDA 510(k) clearance for the BABY DOPPLEX 3000 MK 2 (BD3000). Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Huntleigh Healthcare, Inc. (Cardiff, GB). The FDA issued a Cleared decision on April 25, 2001 after a review of 30 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 Huntleigh Healthcare, Inc. devices

Submission Details

510(k) Number K010889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2001
Decision Date April 25, 2001
Days to Decision 30 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
130d faster than avg
Panel avg: 160d · This submission: 30d
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 213
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