SAM MEDICAL PRODUCTS
Registration 3023316FEI 3023316Tualatin, OR
Owner/operator: SAM Medical Products
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
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- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 13
- Added, last 12 months
- 3
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 13
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| DXC | SAM Junctional TourniquetClamp, Vascular | Class 2 | 21 CFR 870.4450 | K131561 |
| FMI | SAM IONeedle, Hypodermic, Single LumenAdded Nov 17, 2025 | Class 2 | 21 CFR 880.5570 | — |
| FMI | SAM IO Intraosseous Access System; SAM IONeedle, Hypodermic, Single Lumen | Class 2 | 21 CFR 880.5570 | K191488 |
| GBX | SAM ThoraSiteCatheter, Irrigation | Class 1 | 21 CFR 878.4200 | — |
| BSY | FP-909 TVAC - Manual Suction Device; TM-909 TVAC-Manual Suction DeviceCatheters, Suction, TracheobronchialAdded Dec 11, 2025 | Class 1 | 21 CFR 868.6810 | — |
| KMK | SAM IO StabilizerDevice, Intravascular Catheter Securement | Class 1 | 21 CFR 880.5210 | — |
| NAD | SAM Chest SealDressing, Wound, Occlusive | Class 1 | 21 CFR 878.4020 | K102403 |
| GAA | DART; PneumoDart; TPAK 10, TPAKNeedle, Aspiration And Injection, DisposableAdded Dec 11, 2025 | Class 1 | 21 CFR 878.4800 | — |
| IPW | SAM Pelvic Sling II (SM, ST, LG, OD)Orthosis, Sacroiliac, Soft | Class 1 | 21 CFR 890.3490 | — |
| NOC | SAM Splint (multiple)Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | 21 CFR 878.3910 | — |
| OJS | SAM Bleeding Control KitTourniquet Kit | Class 1 | 21 CFR 878.5900 | — |
| GAX | SAM XT; SAM XT Extremity Tourniquet; SAM Extremity TourniquetTourniquet, Nonpneumatic | Class 1 | 21 CFR 878.5900 | — |
and 1 more on your full dossier
What changed
- Nov 17, 2025Listing added: FMI — SAM IO
- Dec 11, 2025Listing added: BSY — FP-909 TVAC - Manual Suction Device; TM-909 TVAC-Manual Suction Device
- Dec 11, 2025Listing added: GAA — DART; PneumoDart; TPAK 10, TPAK