Cleared Traditional

K930227 - MS DISPOSABLE RIGID DOPPLER PROBE

K930227 is the FDA 510(k) clearance for MS DISPOSABLE RIGID DOPPLER PROBE by Meadox Medicals, Div. Boston Scientific Corp.. It is a Class 2 Radiology device (product code DPW) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K930227 · Meadox Medicals, Div. Boston Scientific Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
240d
Days
Class 2
Risk

K930227 is an FDA 510(k) clearance for the MS DISPOSABLE RIGID DOPPLER PROBE. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on September 16, 1993 after a review of 240 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2100 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Meadox Medicals, Div. Boston Scientific Corp. devices

Submission Details

510(k) Number K930227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date September 16, 1993
Days to Decision 240 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 107d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Radiology devices follow this clearance model.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 34
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K930227.
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
K172457 · Deltex Medical Limited · Jun 2018
MONITOR, MODEL HSM-00200
K031153 · Arrow Intl., Inc. · Nov 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · Terumo Cardiovascular Systems Corp. · May 2003
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827 · Hewlett-Packard Co. · Nov 1991
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