510(k) Report

FDA applicant

Seattle Childrens Hospital

Seattle, WA1 decision2013–20131 recall

FDA records 1 decision for Seattle Childrens Hospital (Seattle, WA) in 2013: 1 510(k) clearance. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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 Seattle Childrens Hospital’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1, 1 Class I
2013high 1 (2023) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Seattle Childrens Hospital by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZDVentilator, Non-Continuous (Respirator)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K131502Seattle - PapSeattle Childrens Hospital · 20131 Class I recall

The one decision as Seattle Childrens Hospital →

What has been recalled?

1 recall linked to its devices; the latest:

  • K131502Seattle PAP Plus, MP02260Apr 17, 2023Class I

Other applicant names beginning “Seattle”

FDA records each applicant name separately; these may or may not be the same firm.

Seattle Artificial Kidney Supply Co. 1