Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Jkh USA, LLC · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
360 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K203636PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS,Jkh USA, LLC2021-08-312600
K203635Patient Monitoring CablesJkh USA, LLC2021-02-05530
K203652Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, Jkh USA, LLC2021-01-06230
K202851Spo2 SensorJkh USA, LLC2020-11-27600
K201645Massage Compression BootsJkh USA, LLC2020-09-15900
K201470Disposable Medical Face MaskJkh USA, LLC2020-09-08970
K182671Medi-Direct TENS PenJkh USA, LLC2019-09-213600
K191151JKH Stimulator PlusJkh USA, LLC2019-06-21510
K182203JKH Stimulator PlusJkh USA, LLC2019-03-142110

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda