510(k) Report

FDA applicant

Us Medical Innovations, LLC

Takoma Park, MD5 decisions2011–20240 recalls

FDA records 5 decisions for Us Medical Innovations, LLC (Takoma Park, MD) from 2011 to 2024: 5 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 2 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Us Medical Innovations, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2011: 22019: 12022: 12024: 1
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

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

Planning a device like Us Medical Innovations, LLC’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • GCJLaparoscope, General & Plastic Surgery1decision
  • OABLow Energy Direct Current Thermal Ablation System1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 107 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 103 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC · 20111cites it
  • K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC · 20191cites it

What has FDA decided for it lately?

  • K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC · 2024
  • K212736Canady Flex RoboWristUs Medical Innovations, LLC · 2022
  • K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC · 2019
  • K113500Canady Vieira Hybrid Plasma ScalpelUs Medical Innovations, LLC · 2011
  • K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC · 2011

All 5 as Us Medical Innovations, LLC →