Data / Medical devices / United States / WalkMed Technologies, LLC
WalkMed Technologies, LLC: FDA-registered device maker in Aurora, CO, United States, 3 510(k) clearances
WalkMed Technologies, LLC is registered with the FDA (registration 3000204189) in Aurora, CO, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 1, 1999. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000204189
- Address
- 1390 S Potomac St Ste 110, Aurora, CO, United States, 80012
- Owner or operator
- WalkMed Technologies, LLC (10088987)
- Roles
- Manufacturer
- First device listed
- October 26, 2023
- Registered through
- 2026
- Brand names listed
- WalkMed 350VL Infusion Pump, WalkMed Ambulatory Reservoir Bag, WalkMed Ambulatory Tubing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Infusion | FRN | 2 | 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 |
|---|---|---|---|---|---|---|
| July 1, 1999 | K991275 | WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS | FRN | Substantially Equivalent | Mckinley, Inc. | accessdata.fda.gov |
| December 29, 1987 | K873961 | INFUMED 300 AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | Med Fusion Systems, Inc. | accessdata.fda.gov |
| May 6, 1987 | K870524 | AMBULATORY INFUSION PUMP DRUG RESERVOIR | FRN | Substantially Equivalent | Med Fusion Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 27, 2017 | 78302 | Class II | Terminated | Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL The WalkMed Reservoir Bag is desig | There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirmed to originate from, or near, the reservoirs clearcolored female luer connecter. | accessdata.fda.gov |
| June 14, 2016 | 74437 | Class II | Terminated | Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein. | WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. | accessdata.fda.gov |
| June 14, 2016 | 74436 | Class II | Terminated | The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution. | WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000). | accessdata.fda.gov |
| October 1, 2015 | 72331 | Class II | Terminated | Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner. | The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the actual bag volume. | accessdata.fda.gov |
| February 17, 2014 | 67545 | Class II | Terminated | Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Pat | WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction. | accessdata.fda.gov |
| June 17, 2010 | 56750 | Not yet classified | Terminated | WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia. | Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound. | accessdata.fda.gov |
Compare with other makers
Updated July 1, 1999. 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.