Data / Medical devices / United States / Sam Medical Products
Sam Medical Products: FDA-registered device maker in Tualatin, OR, United States, 4 510(k) clearances
Sam Medical Products is registered with the FDA (registration 3023316) in Tualatin, OR, United States. It lists 12 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 21, 2019. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023316
- Address
- 12200 Sw Tualatin Rd Ste 200, Tualatin, OR, United States, 97062
- Owner or operator
- SAM Medical Products (3023316)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- December 3, 2003
- Registered through
- 2026
- Brand names listed
- Chito-SAM 100, Chito-SAM Active, DART; PneumoDart; TPAK 10, TPAK, FP-909 TVAC - Manual Suction Device; TM-909 TVAC-Manual Suction Device, SAM Bleeding Control Kit, SAM Chest Seal, SAM Chest Seal Combo, SAM Chest Seal Valved 2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Contract manufacturer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Manufacturer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Contract manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Sacroiliac, Soft | IPW | 1 | Manufacturer | accessdata.fda.gov |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 | Manufacturer | accessdata.fda.gov |
| Tourniquet Kit | OJS | 1 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | 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 |
|---|---|---|---|---|---|---|
| November 21, 2019 | K191488 | SAM IO Intraosseous Access System | FMI | Substantially Equivalent | Sam® Medical Products, Inc. | accessdata.fda.gov |
| May 22, 2014 | K133121 | CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT | QSY | Substantially Equivalent | Sam Medical Products | accessdata.fda.gov |
| July 24, 2013 | K131561 | SAM JUNCTIONAL TOURNIQUET | DXC | Substantially Equivalent | Sam Medical Products | accessdata.fda.gov |
| March 3, 2011 | K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | NAD | Substantially Equivalent | Sam Medical Products | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 28, 2022 | 89510 | Class II | Terminated | SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 | Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present. | accessdata.fda.gov |
| May 2, 2018 | 80140 | Class II | Terminated | Part #: SAM XT-M, Model: Tactical Black or Military | Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device. | accessdata.fda.gov |
| August 14, 2014 | 69395 | Class II | Terminated | SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture. | SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Sacroiliac, Soft
- All makers of Device, Intravascular Catheter Securement
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Splint, Extremity, Non-Inflatable, External, Non-Sterile
- All makers of Catheter, Irrigation
- All makers of Clamp, Vascular
Updated November 21, 2019. 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.