Cleared Traditional

K853952 - METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME

K853952 is an FDA 510(k) clearance for METRIFLOW AFM-100 PERIPHERAL VASCULAR B..., manufactured by Metriflow, Inc.. The device is a Class 2 Radiology device with product code DPW cleared through the Traditional 510(k) pathway after a 467-day FDA review.

K853952 · Metriflow, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
467d
Days
Class 2
Risk

K853952 is an FDA 510(k) clearance for the METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Metriflow, Inc. (Milwaukee, US). The FDA issued a Cleared decision on January 5, 1987 after a review of 467 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Metriflow, Inc. devices

FDA 510(k) Submission Details - K853952

510(k) Number K853952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1985
Decision Date January 05, 1987
Days to Decision 467 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
360d slower than avg
Panel avg: 107d · This submission: 467d
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 Radiology 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 K853952.
MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM
K882593 · Cardio Metrics, Inc. · Aug 1988
COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION
K871490 · Ge Medical Systems Information Technologies · Dec 1987
HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD
K872068 · Advanced Technology Laboratories, Inc. · Sep 1987
VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES
K862720 · Sonicaid, Inc. · Nov 1986
HIGH VELOCITY CW DOPPLER SYSTEM
K862841 · Biosound, Inc. · Nov 1986
MILLAR PULSED DOPPLER VELOCIMETER
K860766 · Millar Instruments, Inc. · Jul 1986