Cleared Traditional

K061091 - BABYBEAT CORDLESS

K061091 is an FDA 510(k) clearance for BABYBEAT CORDLESS, manufactured by The Newman Group, LLC. The device is a Class 2 Radiology device with product code KNG cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K061091 · The Newman Group, LLC · Radiology device
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May 2006
Decision
15d
Days
Class 2
Risk

K061091 is an FDA 510(k) clearance for the BABYBEAT CORDLESS. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by The Newman Group, LLC (Chicago, US). The FDA issued a Cleared decision on May 4, 2006 after a review of 15 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 The Newman Group, LLC devices

FDA 510(k) Submission Details - K061091

510(k) Number K061091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2006
Decision Date May 04, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
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 Peers - KNG Monitor, Ultrasonic, Fetal

All 34
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