FDA applicant

Children'S Mercy Hospital

Kansas City, MO2 decisions2015–20190 recalls

FDA records 2 decisions for Children'S Mercy Hospital (Kansas City, MO) from 2015 to 2019: 2 510(k) clearances. All are in product code PIR (Mercy Tape 2d And 3d Models). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Children'S Mercy Hospital’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Children'S Mercy Hospital by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Children'S Mercy Hospital’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Children'S”

FDA records each applicant name separately; these may or may not be the same firm.

Children'S Health First, Inc. 1 Children'S Hospital & Medical Center 1 Children'S Hospital 1

Children'S Mercy Hospital

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Children'S”