Data / Medical devices / United States / A-M Systems
A-M Systems: FDA-registered device maker in Sequim, WA, United States, 4 510(k) clearances
A-M Systems is registered with the FDA (registration 3020614) in Sequim, WA, United States. It lists 13 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 22, 2022. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020614
- Address
- 131 Business Park Loop, Sequim, WA, United States, 98382
- Owner or operator
- A-M SYSTEMS, LLC (3020614)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 5, 1984
- Registered through
- 2026
- Brand names listed
- ABSORBER, ANESTHESIA, BAG, BREATHING, CAL-SYRINGE, CARBON DIOXIDE, EasyOne Filter FT, EasyOne Filter SP, FLOWMETER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Carbon-Dioxide | BSF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bag, Reservoir | BTC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Calibrator, Volume, Gas | BXW | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clip, Nose | BXJ | 1 | Manufacturer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Nebulizer, Manual | EPN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Recorder, Paper Chart | DSF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 22, 2022 | K221250 | EasyOne Filter | CAH | Substantially Equivalent | Ndd Medizintechnik AG | accessdata.fda.gov |
| June 21, 2013 | K130664 | HYRDROMAX HMEF | CAH | Substantially Equivalent | A-M Systems | accessdata.fda.gov |
| June 29, 2007 | K063526 | A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER | CAH | Substantially Equivalent | A-M Systems, Inc. | accessdata.fda.gov |
| November 14, 2000 | K000654 | VBMAX | CAH | Substantially Equivalent | A-M 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 |
|---|---|---|---|---|---|---|
| August 10, 2018 | 81076 | Class II | Terminated | Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect use | Some of the Disposable Smooth Interior Tubing may pull apart when stretched. | accessdata.fda.gov |
| March 31, 2010 | 55294 | Not yet classified | Terminated | ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in conjunction with other respiratory devices containing standard 15 | Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together. | accessdata.fda.gov |
Compare with other makers
- All makers of Absorber, Carbon-Dioxide
- All makers of Calibrator, Volume, Gas
- All makers of Bag, Reservoir
- All makers of Cannula, Nasal, Oxygen
- All makers of Clip, Nose
- All makers of Mask, Oxygen
Updated November 22, 2022. 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.