510(k) · Cleared
Cleared2D Mercy TAPE & 3D Mercy TAPE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Children'S Mercy Hospital · PIR Mercy Tape 2d And 3d Models
Cleared on May 1, 2015 as substantially equivalent to K790089 (Pfizer, Inc., 1979) after a 240-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.
- Decided
- May 1, 2015
- Review
- 240 days
- Class
- Class I
- Product code
- PIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K790089 (1979). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K191174Mercy babyTAPEChildren'S Mercy Hospital · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790089 | Tape Measure | Pfizer, Inc. | 1979 | — |
| 0 (this device) | K142469 | 2D Mercy TAPE & 3D Mercy TAPE | Children'S Mercy Hospital | 2015 | — |
| +1 | K191174 | Mercy babyTAPE | Children'S Mercy Hospital | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PIR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191174 | Mercy babyTAPE | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K191174 (Children'S Mercy Hospital, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PIR devicesPIR Mercy Tape 2d And 3d Models: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PIR
1in 2019
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
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Mercy TAPE device (2D and 3D models) is intended 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 Mercy 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).
The Mercy TAPE device may be less reliable for use in children with known or apparent limb deformities, or abnormal body proportions caused by conditions such as edema or severe malnutrition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142469: 2D Mercy TAPE & 3D Mercy TAPE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142469
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026