Cleared Traditional

K090499 - LIFEDOP MODEL, L350R

K090499 is an FDA 510(k) clearance for LIFEDOP MODEL, manufactured by Summit Doppler Systems, Inc.. The device is a Class 2 Radiology device with product code MAA cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K090499 · Summit Doppler Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
34d
Days
Class 2
Risk

K090499 is an FDA 510(k) clearance for the LIFEDOP MODEL, L350R. Classified as Monitor, Fetal Doppler Ultrasound (product code MAA), Class II - Special Controls.

Submitted by Summit Doppler Systems, Inc. (Golden, US). The FDA issued a Cleared decision on March 31, 2009 after a review of 34 days - a notably fast clearance 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: 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 Summit Doppler Systems, Inc. devices

FDA 510(k) Submission Details - K090499

510(k) Number K090499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2009
Decision Date March 31, 2009
Days to Decision 34 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 107d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.

Regulatory Peers - MAA Monitor, Fetal Doppler Ultrasound

All 7
Devices cleared under the same product code (MAA) and FDA review panel - the closest regulatory comparables to K090499.
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FETAL DOPPLER
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L328 TRANSDUCER
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S5192R TRANSDUCER
K904951 · Acuson Corp. · Apr 1991