Jkh USA, LLC: FDA clearances and approvals
Jkh USA, LLC has 9 FDA 510(k) clearances (first 2019, latest 2021), across 7 product codes in 5 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 90 days, against 161 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 3 | 211 |
| 2020 | 3 | 90 |
| 2021 | 3 | 53 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Jkh USA, LLC's cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 161 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 3 | 3 |
| DQA | Oximeter | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
Review panels
- Neurology (3)
- Cardiovascular (2)
- General Hospital (2)
- Anesthesiology (1)
- Physical Medicine (1)
Most recent Jkh USA, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203636 | PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG | FLL | 2021-08-31 | 260 |
| K203635 | Patient Monitoring Cables | DSA | 2021-02-05 | 53 |
| K203652 | Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D | DXQ | 2021-01-06 | 23 |
| K202851 | Spo2 Sensor | DQA | 2020-11-27 | 60 |
| K201645 | Massage Compression Boots | IRP | 2020-09-15 | 90 |
| K201470 | Disposable Medical Face Mask | FXX | 2020-09-08 | 97 |
| K182671 | Medi-Direct TENS Pen | NUH | 2019-09-21 | 360 |
| K191151 | JKH Stimulator Plus | NUH | 2019-06-21 | 51 |
| K182203 | JKH Stimulator Plus | NUH | 2019-03-14 | 211 |
Recalls
openFDA lists no recalls under a recalling firm named Jkh USA, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Jkh USA, LLC have?
Jkh USA, LLC has 9 FDA 510(k) clearances (first 2019, latest 2021), across 7 product codes in 5 review panels.
How long does FDA take to clear Jkh USA, LLC's 510(k)s?
The median time from FDA receipt to decision across Jkh USA, LLC's cleared 510(k)s is 90 days. Since 2017: 90 days, versus 161 days for all cleared 510(k)s in the same product codes.
What devices does Jkh USA, LLC make?
Its most frequent FDA product codes are NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 3); DQA (Oximeter, 1); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 1).
Has Jkh USA, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Jkh USA, LLC. Related entities may recall under other names.
Next steps
- See all 9 Jkh USA, LLC clearances with predicates and recalls
- Run predicate analysis for product code NUH, Jkh USA, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.