510(k) Report

FDA applicant

Aqueduct Critical Care, Inc.

Bothell, WA4 decisions2016–20180 recalls

FDA records 4 decisions for Aqueduct Critical Care, Inc. (Bothell, WA) from 2016 to 2018: 4 510(k) clearances. All are in product code JXG (Shunt, Central Nervous System And Components). Since 2016 its 510(k)s took a median of 46 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 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, neurology panel, where it files most

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

FDA decisions per year

1in 2018

2016: 12017: 22018: 1
2016high 2 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Aqueduct Critical Care, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aqueduct Critical Care, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JXGShunt, Central Nervous System And Components4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 46 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 96 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K172759Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 20172cite it
  • K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 20161cites it
  • K171586Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 20171cites it

What has FDA decided for it lately?

  • K181301Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2018
  • K172759Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017
  • K171586Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017
  • K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2016

All 4 as Aqueduct Critical Care, Inc. →