510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191174Substantially Equivalent

Mercy babyTAPE

Children'S Mercy Hospital, Kansas City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191174 is the FDA 510(k) clearance record for Mercy babyTAPE, a class I device, cleared for Children'S Mercy Hospital on under FDA product code PIR (Mercy Tape 2d And 3d Models). FDA's definition for product code PIR reads: "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...". FDA records list 2 510(k) clearances for Children'S Mercy Hospital, from to . As of , FDA records show no recalls naming K191174.

Clearance record

Decision date
Received
(162 days to decision)
Product code
PIR Mercy Tape 2d And 3d Models
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Children'S Mercy Hospital 2401 Gilham Rd., Kansas City MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIR

Trailing 12 months

FDA records hold no clearances under product code PIR in the trailing twelve months.

FDA records show no clearances under product code PIR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PIR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260