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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 53
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K061091 · BABYBEAT CORDLESS
Download PDF The Newman Group, LLC