Cleared Traditional

K024197 - LIFEDOP DOPPLER

K024197 is an FDA 510(k) clearance for LIFEDOP DOPPLER, manufactured by Summit Doppler Systems, Inc.. The device is a Class 2 Radiology device with product code KNG cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K024197 · Summit Doppler Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
14d
Days
Class 2
Risk

K024197 is an FDA 510(k) clearance for the LIFEDOP DOPPLER. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Summit Doppler Systems, Inc. (Arvada, US). The FDA issued a Cleared decision on January 3, 2003 after a review of 14 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 - K024197

510(k) Number K024197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2002
Decision Date January 03, 2003
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KNG Device Classification - Class 2, Special Controls

Product Code KNG Monitor, Ultrasonic, Fetal
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 America, Inc.

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 - KNG Monitor, Ultrasonic, Fetal

All 50
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K024197.
OB1 OBSTETRICAL DOPPLER
K033156 · D. E. Hokanson, Inc. · Dec 2003
HANDYDOP
K030466 · Elcat, GmbH · Sep 2003
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
K031504 · Koven Technology, Inc. · Jul 2003
ECHO SOUNDER, ES-102EX
K023143 · Koven Technology, Inc. · Dec 2002
BABYCOM
K013547 · Pmg Medica , Ltd. · Feb 2002
CADENCE DOPPLER ULTRASOUND SYSTEM
K991441 · Medasonics, Inc. · Dec 1999
K024197 · LIFEDOP DOPPLER
Download PDF FDA Summary Summit Doppler System…