510(k) Report

FDA applicant

Sam Medical Products

Wilsonville, OR5 decisions2011–20192 recalls

FDA records 5 decisions for Sam Medical Products (Wilsonville, OR) from 2011 to 2019: 5 510(k) clearances. Most are in product codes DXC (Clamp, Vascular) and NAD (Dressing, Wound, Occlusive). Its devices cite 8 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Sam® Medical Products, 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 Sam Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2011: 12013: 22014: 12019: 1
2011high 2 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2022

2014: 12022: 1
2011high 1 (2014) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Sam Medical Products by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sam Medical Products’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?

  • DXCClamp, Vascular2decisions
  • NADDressing, Wound, Occlusive1decision
  • FMINeedle, Hypodermic, Single Lumen1decision
  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active, 4INX4IN,Chito-Sam…Sam Medical Products · 20143cite it
  • K131561Sam Junctional TourniquetSam Medical Products · 20132cite it
  • K191488SAM IO Intraosseous Access SystemSam® Medical Products, Inc. · 20191cites it
  • K123694Sam Junctional TourniquetSam Medical Products · 20131cites it

What has FDA decided for it lately?

  • K191488SAM IO Intraosseous Access SystemSam® Medical Products, Inc. · 2019
  • K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active, 4INX4IN,Chito-Sam…Sam Medical Products · 2014
  • K131561Sam Junctional TourniquetSam Medical Products · 20131 recall
  • K123694Sam Junctional TourniquetSam Medical Products · 20131 recall
  • K102403Sam Chest Seal with Vavle; Sam Chest SealSam Medical Products · 20111 recall

All 4 as Sam Medical Products →The one decision as Sam® Medical Products, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K102403SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09Jan 28, 2022Class II
  • K123694SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models…Aug 14, 2014Class II