Data / Medical devices / United States / Magnolia Medical Technologies, Inc.
Magnolia Medical Technologies, Inc.: FDA-registered device maker in Seattle, WA, United States, 3 510(k) clearances
Magnolia Medical Technologies, Inc. is registered with the FDA (registration 3009976527) in Seattle, WA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 25, 2025. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3009976527
- Address
- 220 W Mercer St. Suite 100, Seattle, WA, United States, 98119
- Owner or operator
- Magnolia Medical Technologies (10042579)
- Roles
- Manufacturer
- First device listed
- September 18, 2020
- Registered through
- 2027
- Brand names listed
- Steripath Flow Blood Collection System, Steripath Gen2 Blood Collection System, Steripath Micro Blood Collection System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 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 |
|---|---|---|---|---|---|---|
| September 25, 2025 | K251812 | Steripath® Flow Blood Collection System | JKA | Substantially Equivalent | Magnolia Medical Technologies | accessdata.fda.gov |
| November 30, 2022 | K222299 | Steripath Micro Blood Collection System | JKA | Substantially Equivalent | Magnolia Medical Technologies | accessdata.fda.gov |
| February 28, 2020 | K192247 | Steripath Gen2 Blood Collection System | JKA | Substantially Equivalent | Magnolia Medical Technologies, 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 |
|---|---|---|---|---|---|---|
| November 2, 2021 | 88919 | Class II | Terminated | The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / S | Due to an uptick of complaints associated with premature needle retraction of blood collection system. | accessdata.fda.gov |
| August 2, 2021 | 88338 | Class II | Terminated | Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer Blood Collection or Urine Collection Tubes. | Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU). | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
Updated September 25, 2025. 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.