510(k) Report

FDA applicant

Tz Medical, Inc.

Lake Oswego, OR16 decisions1992–20262 recalls

FDA records 16 decisions for Tz Medical, Inc. (Lake Oswego, OR) from 1992 to 2026: 15 510(k) clearances and 1 original PMA approval. Most are in product codes DXH (Transmitters And Receivers…) and DXC (Clamp, Vascular). Its devices cite 12 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

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

FDA decisions per year

1in 2024

2011: 12017: 12018: 12024: 12026 (partial year): 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2013: 12016: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Tz Medical, 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?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone4decisions
  • DXCClamp, Vascular3decisions
  • DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2decisions
  • HBLHolder, Head, Neurosurgical (Skull Clamp)1decision
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision
  • DSIDetector And Alarm, Arrhythmia1decision

Also: DRF (1), QSY (1), LDD (1), MKJ (1).

Whose devices does it build on?

Its devices cite 12 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 1 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.

  • K923930Electrocardiograph TransmitterTz Medical, Inc. · 19925cite it
  • K040208Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. · 20044cite it
  • K973132EZ Hold 1 LBS., EZ Hold 2 LBSTz Medical, Inc. · 19982cite it
  • K163322TZ SKULL PIN AdultTz Medical, Inc. · 20171cites it
  • K173563Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 20181cites it

What has FDA decided for it lately?

  • K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2026
  • P200005TZ Medical Defibrillation Electrodes, Accessory Cables, and ConnectorsTz Medical, Inc. · 2024
  • K173563Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2018
  • K163322TZ SKULL PIN AdultTz Medical, Inc. · 2017
  • K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc. · 2011
  • K062577V1 Multi-Port Connector, Model Pad V1-MPCTz Medical, Inc. · 2006
  • K040208Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. · 20041 recall
  • K021421Padtac Electrophysiology Recording Catheters, Junction Cable Connector & CableTz Medical, Inc. · 2003

All 16 as Tz Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K040208Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the…Jul 7, 2016Class II
  • K983196adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model…Apr 30, 2013Class II