Cleared Traditional

K901015 - WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC

K901015 is an FDA 510(k) clearance for WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC, manufactured by Wright Medical Corp.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K901015 · Wright Medical Corp. · Cardiovascular device
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Nov 1990
Decision
245d
Days
Class 2
Risk

K901015 is an FDA 510(k) clearance for the WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Wright Medical Corp. (Kirkland, US). The FDA issued a Cleared decision on November 5, 1990 after a review of 245 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Wright Medical Corp. devices

FDA 510(k) Submission Details - K901015

510(k) Number K901015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1990
Decision Date November 05, 1990
Days to Decision 245 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 81
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K901015.
INTERSPEC APOGEE, MODIFICATION
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FLOWIRE AND FLOMAP
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DOPPLER NEEDLE AND FLOW MONITOR
K903625 · Peripheral Systems Group · Nov 1990
ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER
K901335 · Ge Medical Systems Information Technologies · Aug 1990
MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND
K902088 · Hewlett-Packard Co. · Aug 1990
MODIFIED FLOCATH PULMONARY ARTERY CATHETER
K901733 · Cardio Metrics, Inc. · Jul 1990