Cleared Traditional

K895909 - SONICAID MODEL VASOFLO 4

K895909 is an FDA 510(k) clearance for SONICAID MODEL VASOFLO 4, manufactured by Oxford Medilog, Inc.. The device is a Class 2 Radiology device with product code MAA cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K895909 · Oxford Medilog, Inc. · Radiology device
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Jul 1990
Decision
272d
Days
Class 2
Risk

K895909 is an FDA 510(k) clearance for the SONICAID MODEL VASOFLO 4. Classified as Monitor, Fetal Doppler Ultrasound (product code MAA), Class II - Special Controls.

Submitted by Oxford Medilog, Inc. (Clearwater, US). The FDA issued a Cleared decision on July 9, 1990 after a review of 272 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2660 - 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 Oxford Medilog, Inc. devices

FDA 510(k) Submission Details - K895909

510(k) Number K895909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1989
Decision Date July 09, 1990
Days to Decision 272 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 107d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAA Device Classification - Class 2, Special Controls

Product Code MAA Monitor, Fetal Doppler Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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.