510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Magnolia Medical Technologies, Inc.

Seattle, WA, US

MAGNOLIA MEDICAL TECHNOLOGIES, INC. appears in FDA device records in Seattle, WA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 4 510(k) clearances for Magnolia Medical Technologies, Inc. between 2020 and 2025. The busiest year on record is 2020, with 2. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Magnolia Medical Technologies, Inc., by decision year
YearClearances
20202
20221
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251812Steripath® Flow™ Blood Collection SystemJKASubstantially Equivalent
K222299Steripath Micro Blood Collection SystemJKASubstantially Equivalent
K200661Steripath Micro Blood Collection SystemFPASubstantially Equivalent
K192247Steripath Gen2 Blood Collection SystemJKASubstantially Equivalent

Registered establishments

FDA registered establishments for Magnolia Medical Technologies, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30099765273009976527MAGNOLIA MEDICAL TECHNOLOGIES, INC.220 W Mercer St., Seattle, WA 98119 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0318-2022The 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 / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long NeckDue to an uptick of complaints associated with premature needle retraction of blood collection system.Class IITerminated
Z-2393-2021Steripath 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).Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain