510(k) Report

FDA product code · General hospital

Mercy Tape 2d And 3d Models

PIRClass I21 CFR 878.4800510(k) required2 decisions since 20150 recalls

2 FDA decisions since 2015. No recall names this code. The most-cited predicate is K142469, named by 1 later device.

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).

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of PIR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PIR

1in 2019

2015: 12019: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PIR

Too few PIR 510(k)s in any year since 2007 to give a median.

Recalls per year · PIR

No recall names PIR since 2007.

Adverse event reports per year · PIR

No MAUDE report names PIR since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PIR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PIR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PIR devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K1424692D Mercy TAPE & 3D Mercy TAPEChildren'S Mercy Hospital · 20151cites it

Which PIR devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K191174Mercy babyTAPEChildren'S Mercy Hospital · 20192generations
  • K1424692D Mercy TAPE & 3D Mercy TAPEChildren'S Mercy Hospital · 20151generation

What has FDA decided in PIR lately?

  • K191174Mercy babyTAPEChildren'S Mercy Hospital · 2019
  • K1424692D Mercy TAPE & 3D Mercy TAPEChildren'S Mercy Hospital · 2015

All 2 PIR decisions →

Related product codes

Other codes under 21 CFR 878.4800.

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