510(k) Report

FDA applicant

Watermark Medical

Brookfield, WI4 decisions2012–20170 recalls

FDA records 4 decisions for Watermark Medical (Brookfield, WI) from 2012 to 2017: 4 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and DXN (System, Measurement, Blood-Pressure…). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Watermark Medical, Inc.”.

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 Watermark Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2012: 32017: 1
2012high 3 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Watermark Medical by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Watermark Medical’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?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision
  • MNRVentilatory Effort Recorder1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K120320Connected Care Clinical ApplicationWatermark Medical, Inc. · 20121cites it

What has FDA decided for it lately?

  • K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical · 2017
  • K120320Connected Care Clinical ApplicationWatermark Medical, Inc. · 2012
  • K120325Connected Care Mobile ApplicationWatermark Medical · 2012
  • K120470MIPALWatermark Medical · 2012

All 3 as Watermark Medical →The one decision as Watermark Medical, Inc. →