Cleared Traditional

K850071 - TECA MF-20 MICROVASCULAR DOPPLER

K850071 is an FDA 510(k) clearance for TECA MF-20 MICROVASCULAR DOPPLER, manufactured by Teca, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K850071 · Teca, Inc. · Radiology device
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Apr 1985
Decision
83d
Days
Class 2
Risk

K850071 is an FDA 510(k) clearance for the TECA MF-20 MICROVASCULAR DOPPLER. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Teca, Inc. (Pleasantiville, US). The FDA issued a Cleared decision on April 2, 1985 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teca, Inc. devices

FDA 510(k) Submission Details - K850071

510(k) Number K850071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1985
Decision Date April 02, 1985
Days to Decision 83 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
24d faster than avg
Panel avg: 107d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 873
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K850071.
ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER
K882737 · Acuson Corp. · Sep 1988
5 MHZ DOPPLER OUTRIGGER
K872817 · Philips Ultrasound, Inc. · Feb 1988
DOPPLER UNIT, SDS-100A
K863577 · Toshiba Medical Systems · Feb 1987
PULSED DOPPLER OPTION, CONTINU-WAVE
K842407 · General Electric Co. · Feb 1985
AUTO DII MULTI FREQUENCY
K844293 · Technicare Corp. · Feb 1985
PICKER ARTIS ULTRASOUND IMAGING SYS
K842055 · Philips Medical Systems (Cleveland), Inc. · Aug 1984