510(k) Report

FDA applicant

Magnolia Medical Technologies

Seattle, WA4 decisions2020–20252 recalls

FDA records 4 decisions for Magnolia Medical Technologies (Seattle, WA) from 2020 to 2025: 4 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 157 days from receipt to decision, against 173 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Magnolia Medical Technologies, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Magnolia Medical Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 22022: 12025: 1
2020high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

2in 2021

2021: 2
2020high 2 (2021) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Magnolia Medical Technologies by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection3decisions
  • FPASet, Administration, Intravascular1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 157 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 173 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K192247Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 20203cite it
  • K200661Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc. · 20202cite it

What has FDA decided for it lately?

  • K251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies · 2025
  • K222299Steripath Micro Blood Collection SystemMagnolia Medical Technologies · 2022
  • K200661Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020
  • K192247Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 20202 recalls

All 2 as Magnolia Medical Technologies →All 2 as Magnolia Medical Technologies, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K192247The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN /…Nov 2, 2021Class II
  • K192247Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter…Aug 2, 2021Class II