510(k) Report

FDA applicant

Mirador Biomedical, Inc.

Seattle, WA4 decisions2010–20140 recalls

FDA records 4 decisions for Mirador Biomedical, Inc. (Seattle, WA) from 2010 to 2014: 4 510(k) clearances. All are in product code DRS (Transducer, Blood-Pressure, Extravascular). Its devices cite 7 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mirador Biomedical”.

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 Mirador Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2010: 12011: 22014: 1
2010high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Mirador Biomedical, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • DRSTransducer, Blood-Pressure, Extravascular4decisions

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 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.

  • K101518Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 20103cite it
  • K112203Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure, Epidural Assist…Mirador Biomedical, Inc. · 20112cite it
  • K103715Compass Vascular Access / Access Port / Lumbar Puncture / Intracranial PressureMirador Biomedical, Inc. · 20111cites it
  • K133624Compass CT, Compass CT PortMirador Biomedical · 20141cites it

What has FDA decided for it lately?

  • K133624Compass CT, Compass CT PortMirador Biomedical · 2014
  • K112203Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure, Epidural Assist…Mirador Biomedical, Inc. · 2011
  • K103715Compass Vascular Access / Access Port / Lumbar Puncture / Intracranial PressureMirador Biomedical, Inc. · 2011
  • K101518Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010

All 3 as Mirador Biomedical, Inc. →The one decision as Mirador Biomedical →