K-Jump Health Co., Ltd.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “K-Jump Health Co., Ltd.” (first 1990, latest 2018), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 112 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 256 |
| 2013 | 1 | 297 |
| 2014 | 1 | 81 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 244 |
| 2018 | 1 | 189 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name K-Jump Health Co., Ltd. took a median 216 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 194 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 14 | 14 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 8 | 8 |
| CAF | Nebulizer (Direct Patient Interface) | 3 | 3 |
| BZH | Meter, Peak Flow, Spirometry | 1 | 1 |
Review panels
- General Hospital (14)
- Cardiovascular (8)
- Anesthesiology (4)
Most recent K-Jump Health Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180714 | Probe Covers for Thermometers | FLL | 2018-09-24 | 189 |
| K170262 | Digital Thermometer | FLL | 2017-09-28 | 244 |
| K141505 | BASAL DIGITAL THERMOMETER | FLL | 2014-08-26 | 81 |
| K121520 | ULTRASONIC NEBULIZER (MESH TYPE) | CAF | 2013-03-15 | 297 |
| K120711 | NON-CONTACT THERMOMETER | FLL | 2012-11-19 | 256 |
| K103617 | DIGITAL FOREHEAD THERMOMETER | FLL | 2011-04-04 | 115 |
| K102947 | NON-CONTACT INFRARED THERMOMETER | FLL | 2011-02-25 | 144 |
| K092335 | PEAK EXPIRATORY FLOW METER, KN-9710 | BZH | 2010-04-09 | 248 |
| K092806 | AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 | DXN | 2009-10-09 | 28 |
| K083256 | ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 | CAF | 2009-06-26 | 234 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named K-Jump Health Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under K-Jump Health Co., Ltd. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under K-Jump Health Co., Ltd.?
FDA lists 26 510(k) clearances under the applicant name “K-Jump Health Co., Ltd.” (first 1990, latest 2018), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by K-Jump Health Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name K-Jump Health Co., Ltd. is 112 days.
Which FDA product codes appear under K-Jump Health Co., Ltd.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 14); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 8); CAF (Nebulizer (Direct Patient Interface), 3).
Next steps
- See all 26 K-Jump Health Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FLL, K-Jump Health Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.