Data / Medical devices / Adjunctive Open Loop Fluid Therapy Recommender
Adjunctive Open Loop Fluid Therapy Recommender (QMS): 7 FDA-registered makers in 5 countries
7 establishments in 5 countries are registered with the FDA to make Adjunctive Open Loop Fluid Therapy Recommender (product code QMS, Class 2, 21 CFR 870.5600). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on August 2, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QMS
- Device class
- 2
- Regulation
- 870.5600
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 1 |
| Mexico | 1 |
| Dominican Republic | 1 |
| Malaysia | 1 |
Makers of Adjunctive Open Loop Fluid Therapy Recommender
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 |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 1 | August 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BENCHMARK ELECTRONICS San Jorge | Tlajomulco de Zuniga Jalisco, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG | HAINA San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Supercomal Medical Products, Sdn Bhd | SUNGAI PETANI Kedah, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 2, 2024. 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.