510(k) Report

FDA applicant

F Care Systems USA, LLC

Miami, FL4 decisions2021–20260 recalls

FDA records 4 decisions for F Care Systems USA, LLC (Miami, FL) from 2021 to 2026: 4 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and ONQ (Electrosurgical Coagulation For Aesthetic). Since 2016 its 510(k)s took a median of 176 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 7 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 F Care Systems USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12023: 12025: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — F Care Systems USA, LLC by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like F Care Systems USA, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • ONQElectrosurgical Coagulation For Aesthetic1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 176 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 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.

  • K210077MED RF 4000F Care Systems USA, LLC · 20211cites it
  • K220725HPR45iF Care Systems USA, LLC · 20231cites it

What has FDA decided for it lately?

  • K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC · 2026
  • K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC · 2025
  • K220725HPR45iF Care Systems USA, LLC · 2023
  • K210077MED RF 4000F Care Systems USA, LLC · 2021

All 4 as F Care Systems USA, LLC →