510(k) Report

FDA applicant

Srs Medical Systems, Inc.

Redmond, WA3 decisions2000–20010 recalls

FDA records 3 decisions for Srs Medical Systems, Inc. (Redmond, WA) from 2000 to 2001: 3 510(k) clearances. Most are in product codes HCC (Device, Biofeedback) and HIR (Perineometer). 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 Srs Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Srs Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Srs Medical Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HCCDevice, Biofeedback2decisions
  • HIRPerineometer1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K003127Regain DesktopSrs Medical Systems, Inc. · 20011cites it
  • K003367Orion PlatinumSrs Medical Systems, Inc. · 20011cites it

What has FDA decided for it lately?

  • K003127Regain DesktopSrs Medical Systems, Inc. · 2001
  • K003367Orion PlatinumSrs Medical Systems, Inc. · 2001
  • K002834SRS Vaginal Emg/Stimulation Perineometer Sensor SRS Anal Emg/Stimulation Perineometer SensorSrs Medical Systems, Inc. · 2000

All 3 as Srs Medical Systems, Inc. →