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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv Sud America, Inc.
DAWN TIBODEAU

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAA Monitor, Fetal Doppler Ultrasound

All 8
Devices cleared under the same product code (MAA) and FDA review panel - the closest regulatory comparables to K090499.
ULTRASONIC TABLETOP DOPPLER
K102138 · Edan Instruments, Inc. · Oct 2010
GE SONOCHROME
K915138 · GE Medical Systems · Oct 1992
FETAL DOPPLER
K905536 · Toshiba America Medical Systems, In.C · Apr 1992
L582 TRANSDUCER
K904600 · Acuson Corp. · Jun 1991
L328 TRANSDUCER
K905456 · Acuson Corp. · May 1991
S5192R TRANSDUCER
K904951 · Acuson Corp. · Apr 1991
K090499 · LIFEDOP MODEL, L350R
Download PDF FDA Summary Summit Doppler System…