Cleared Traditional

Mercy babyTAPE (K191174) - FDA 510(k) Clearance

Class I General Hospital device.

K191174 · Children'S Mercy Hospital · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
162d
Days
Class 1
Risk

K191174 is an FDA 510(k) clearance for the Mercy babyTAPE. Classified as Mercy Tape 2d And 3d Models (product code PIR), Class I - General Controls.

Submitted by Children'S Mercy Hospital (Kansas City, US). The FDA issued a Cleared decision on October 10, 2019 after a review of 162 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4800 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Children'S Mercy Hospital devices

Submission Details

510(k) Number K191174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2019
Decision Date October 10, 2019
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 129d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PIR Mercy Tape 2d And 3d Models
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
Definition The Mercy Tape Device (2d And 3d Models) Is Intended For Use By Health Care Professionals To Estimate The Body Weight Of Pediatric Patients Between The Ages Of 2 Months And 16 Years, Using Linear Measurements From Specific Anatomical Landmarks Made With The Tape Device For Humeral Length (hl, For The 2d Model) Or Half-humeral Length (hhl, For The 3d Model) And The Mid-upper Arm Circumference (muac).
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

The Emmes Company, LLC
Susan Abdel-Rahman, Pharmd.

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.