Data / Medical devices / Pediatric Position Holder
Pediatric Position Holder (PRN): 13 FDA-registered makers in 6 countries
13 establishments in 6 countries are registered with the FDA to make Pediatric Position Holder (product code PRN, Class 1, 21 CFR 880.5680). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PRN
- Device class
- 1
- Regulation
- 880.5680
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Mexico | 1 |
| Vietnam | 1 |
| Austria | 1 |
| China | 1 |
| Taiwan | 1 |
Makers of Pediatric Position Holder
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bird & Cronin, LLC | Eagan, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Domico Med-Device, LLC | Fenton, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Domico Med-Device, LLC | Las palomas Guanajuato, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Respiratory Solutions, Inc. (dba) Respiralogics | Reno, NV, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hameco Hy Co., Ltd | Hung Yen Province, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kohlbrat & Bunz | Radstadt Salzburg, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou Shandong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marketlab Incorporated | Caledonia, MI, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Megaforce Company Limited | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pottymd, LLC | Knoxville, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smoltap, Inc. | Providence, RI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| voss medical products | San Antonio, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.