Data / Medical devices / United States / Aquabiliti
Aquabiliti: FDA-registered device maker in Nashville, TN, United States, 3 510(k) clearances
Aquabiliti is registered with the FDA (registration 1057300) in Nashville, TN, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated August 13, 2014. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1057300
- FEI number
- 1000151124
- Address
- 5209 Linbar Dr Ste 640, Nashville, TN, United States, 37211
- Owner or operator
- MRP, LLC (9076844)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- May 22, 2014
- Registered through
- 2026
- Brand names listed
- AMUSA Flush Syringe / Aquastat Saline Flush, AquastatSFR 10mL Sterile Saline flush, AquastatSFR 20mL Sterile Saline flush
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Saline, Vascular Access Flush | NGT | 2 | Complaint file establishment, Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 13, 2014 | K133685 | 0.9% SODIUM CHLORIDE FLUSH SYRINGE | NGT | Substantially Equivalent | Am USA | accessdata.fda.gov |
| July 12, 2012 | K120836 | 0.9% SODIUM CHLORIDE FLISH SYRINGE | NGT | Substantially Equivalent | Am USA | accessdata.fda.gov |
| January 30, 2012 | K113555 | AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE | NGT | Substantially Equivalent | Am USA | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 28, 2023 | 93848 | Class II | Ongoing | AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile. | The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months. | accessdata.fda.gov |
| July 2, 2015 | 71735 | Class II | Terminated | 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution. | Procedures for the acceptance and control of in-process product have not been adequately established. | accessdata.fda.gov |
| April 27, 2015 | 71175 | Class II | Terminated | 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe. | Incorrect expiration date on label | accessdata.fda.gov |
| February 9, 2015 | 70974 | Class II | Terminated | T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe. | Incorrect labeling of the expiration date | accessdata.fda.gov |
| August 15, 2012 | 63105 | Class III | Terminated | 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe | One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL. | accessdata.fda.gov |
Compare with other makers
Updated February 22, 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.