FDA product code PIR: Mercy Tape 2d And 3d Models
PIR is the FDA product code for mercy tape 2d and 3d models. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under PIR. The average 510(k) review took 201 days (median 201).
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).
Classification
| Field | Value |
|---|---|
| Device name | Mercy Tape 2d And 3d Models |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PIR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 162 |
Compare with all 510(k) review times · Search every PIR clearance
Top PIR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Children'S Mercy Hospital | 2 | 2019-10-10 |
Most recent PIR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191174 | Children'S Mercy Hospital | Mercy babyTAPE | 2019-10-10 | 162 |
| K142469 | Children'S Mercy Hospital | 2D Mercy TAPE & 3D Mercy TAPE | 2015-05-01 | 240 |
Recalls for PIR devices
openFDA lists no recalls for product code PIR.
Frequently asked questions
What is FDA product code PIR?
PIR is the FDA product code for mercy tape 2d and 3d models. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General Hospital panel.
What device class is PIR?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIR?
Across 2 cleared submissions the average was 201 days from receipt to decision (median 201).
Which companies have the most PIR clearances?
Children'S Mercy Hospital (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PIR
- Run a recall and safety report across every PIR manufacturer
- Watch product code PIR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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