510(k) Report

FDA applicant

Jkh USA, LLC

Walnut, CA9 decisions2019–20210 recalls

FDA records 9 decisions for Jkh USA, LLC (Walnut, CA) from 2019 to 2021: 9 510(k) clearances. Most are in product codes NUH (Stimulator, Nerve, Transcutaneous…) and IRP (Massager, Powered Inflatable Tube). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 164 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 1 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, neurology panel, where it files most

How often FDA has decided Jkh USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2021

2019: 32020: 32021: 3
2019high 3 (2019) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Jkh USA, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jkh USA, 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?

  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter3decisions
  • IRPMassager, Powered Inflatable Tube1decision
  • FXXMask, Surgical1decision
  • DXQBlood Pressure Cuff1decision
  • DQAOximeter1decision
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision

Also: FLL (1).

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 164 days; 7 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 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.

  • K182203JKH Stimulator PlusJkh USA, LLC · 20193cite it
  • K191151JKH Stimulator PlusJkh USA, LLC · 20193cite it
  • K203635Patient Monitoring CablesJkh USA, LLC · 20212cite it
  • K202851Spo2 SensorJkh USA, LLC · 20201cites it

What has FDA decided for it lately?

  • K203636PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS…Jkh USA, LLC · 2021
  • K203635Patient Monitoring CablesJkh USA, LLC · 2021
  • K203652Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D…Jkh USA, LLC · 2021
  • K202851Spo2 SensorJkh USA, LLC · 2020
  • K201645Massage Compression BootsJkh USA, LLC · 2020
  • K201470Disposable Medical Face MaskJkh USA, LLC · 2020
  • K182671Medi-Direct TENS PenJkh USA, LLC · 2019
  • K191151JKH Stimulator PlusJkh USA, LLC · 2019

All 9 as Jkh USA, LLC →