510(k) Report

FDA applicant

Medtronic Blood Management

Parker, CO3 decisions1998–19981 recall

FDA records 3 decisions for Medtronic Blood Management (Parker, CO) in 1998: 3 510(k) clearances. Most are in product codes CAC (Apparatus, Autotransfusion) and JPA (System, Multipurpose For In Vitro Coagulation…). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Medtronic Blood Management’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Blood Management since 2007.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Blood Management by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CACApparatus, Autotransfusion2decisions
  • JPASystem, Multipurpose For In Vitro Coagulation Studies1decision

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K972894Autotransfusion Appartus (Autolog)Medtronic Blood Management · 19982cite it
  • K982755Modification of Autotransfusion Apparatus (Autolog)Medtronic Blood Management · 19981cites it

What has FDA decided for it lately?

  • K982755Modification of Autotransfusion Apparatus (Autolog)Medtronic Blood Management · 1998
  • K981815Heptrac Electronic Quality ControlMedtronic Blood Management · 1998
  • K972894Autotransfusion Appartus (Autolog)Medtronic Blood Management · 19981 recall

All 3 as Medtronic Blood Management →

What has been recalled?

1 recall linked to its devices; the latest:

  • K051303Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord…Apr 21, 2010