Data / Medical devices / United States / The Metrix Company
The Metrix Company: FDA-registered device maker in Dubuque, IA, United States, 2 510(k) clearances
The Metrix Company is registered with the FDA (registration 1937141) in Dubuque, IA, United States. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 2, 2003. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1937141
- FEI number
- 1000117446
- Address
- 4400 Chavenelle Rd, Dubuque, IA, United States, 52002
- Owner or operator
- The Metrix Company (1937141)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 19, 1997
- Registered through
- 2026
- Brand names listed
- BIOACCESS, Evacu-Stat, Harvest Technologies, IMed Products, Infu-Stat, LIPOGRAFTER, MARROWPREP, MSD CORMIX and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Contract manufacturer | accessdata.fda.gov |
| Bone Marrow Collection/Transfusion Kit | LWE | 2 | Contract manufacturer | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Contract manufacturer | accessdata.fda.gov |
| Evacuator, Gastro-Urology | KQT | 2 | Contract manufacturer | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Suction, Lipoplasty | MUU | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2003 | K030888 | EVA EMPTY SOLUTION CONTAINER | KPE | Substantially Equivalent | Metrix Co. | accessdata.fda.gov |
| October 16, 1984 | K843523 | EMPTY SOLUTION TRANSFER CONTAINER 1000 | KPE | Substantially Equivalent | Polymer Technology Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 9, 2024 | 95499 | Class II | Ongoing | VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | accessdata.fda.gov |
| September 21, 2018 | 83509 | Class II | Ongoing | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under nor | Potential for leaking product | accessdata.fda.gov |
| September 13, 2017 | 78117 | Class II | Terminated | SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R | The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes. | accessdata.fda.gov |
| June 23, 2016 | 74043 | Class II | Terminated | AUTOCOMP6 XPS High Speed Compounder REF 58810 | An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specificatio | accessdata.fda.gov |
Compare with other makers
- All makers of Evacuator, Gastro-Urology
- All makers of Container, I.V.
- All makers of Syringe, Piston
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Bone Marrow Collection/Transfusion Kit
- All makers of System, Suction, Lipoplasty
Updated November 8, 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.