K-Jump Health Co., Ltd.: FDA clearances and approvals
K-Jump Health Co., Ltd. has 26 FDA 510(k) clearances (first 1990, latest 2018), across 4 product codes in 3 review panels. Median 510(k) review time: 112 days.
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, K-Jump Health Co., Ltd.'s cleared 510(k)s 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of K-Jump Health Co., Ltd.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does K-Jump Health Co., Ltd. have?
K-Jump Health Co., Ltd. has 26 FDA 510(k) clearances (first 1990, latest 2018), across 4 product codes in 3 review panels.
How long does FDA take to clear K-Jump Health Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across K-Jump Health Co., Ltd.'s cleared 510(k)s is 112 days.
What devices does K-Jump Health Co., Ltd. make?
Its most frequent FDA product codes are FLL (Continuous Measurement Thermometer, 14); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 8); CAF (Nebulizer (Direct Patient Interface), 3).
Has K-Jump Health Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching K-Jump Health Co., Ltd. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.