510(k) Report

FDA applicant

Apmtd, Inc.

Wilmington, MA2 decisions2023–20230 recalls

FDA records 2 decisions for Apmtd, Inc. (Wilmington, MA) in 2023: 2 510(k) clearances. All are in product code DWA (Control, Pump Speed, Cardiopulmonary Bypass). Its devices cite 2 predicates, 1 of them its own earlier devices. No 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, cardiovascular panel, where it files most

How often FDA has decided Apmtd, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Apmtd, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DWAControl, Pump Speed, Cardiopulmonary Bypass2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221491Anivia SG1000 Pump ConsoleApmtd, Inc. · 20231cites it

What has FDA decided for it lately?

  • K230698Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
  • K221491Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023

All 2 as Apmtd, Inc. →