Data / Medical devices / Aid, Cardiopulmonary Resuscitation
Aid, Cardiopulmonary Resuscitation (LIX): 8 FDA-registered makers in 6 countries
8 establishments in 6 countries are registered with the FDA to make Aid, Cardiopulmonary Resuscitation (product code LIX, Class 2, 21 CFR 870.5210). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on March 6, 2021, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LIX
- Device class
- 2
- Regulation
- 870.5210
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| Norway | 2 |
| United States | 2 |
| Mexico | 1 |
| China | 1 |
| United Kingdom | 1 |
| Switzerland | 1 |
Makers of Aid, Cardiopulmonary Resuscitation
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 |
|---|---|---|---|---|---|---|---|---|
| Laerdal Medical A/S | STAVANGER Rogaland, Norway | Manufacturer, Specification developer | 2 | December 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Laerdal Medical AS, Stavanger Manufacturing | Sandnes Rogaland, Norway | Manufacturer | 1 | March 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Amphenol Alden Products Company | Hermosillo Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remote Diagnostic Technologies Ltd. | FARNBOROUGH Hampshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schiller AG | BAAR Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zoll Medical Corporation | Chelmsford, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 6, 2021. 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.