Zhejiang Kindly Medical Devices Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Zhejiang Kindly Medical Devices Co., Ltd.” (first 2018, latest 2022), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 226 days. Since 2017 the median was 226 days, against 180 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 3 | 226 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 212 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zhejiang Kindly Medical Devices Co., Ltd. took a median 226 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 180 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
Review panels
- General Hospital (3)
- Anesthesiology (1)
- Clinical Chemistry (1)
Most recent Zhejiang Kindly Medical Devices Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223334 | Sterile Hypodermic Needles for Single Use | FMI | 2022-12-16 | 45 |
| K213183 | Safety Insulin Pen Needles | FMI | 2022-10-14 | 380 |
| K181069 | Disposable Insulin Pen Needle | FMI | 2018-08-28 | 127 |
| K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder | JKA | 2018-06-04 | 264 |
| K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles | BSP | 2018-01-05 | 226 |
Recalls
6 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-08-24.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd (20 510(k)s)
- Zhejiang Chuangxiang Medical Technology Co., Ltd. (14 510(k)s)
- ZheJiang Decans Medical Devices Co., Ltd. (11 510(k)s)
- Zhejiang Curaway Medical Technology Co., Ltd. (7 510(k)s)
- Zhejiang Longterm Medical Technology Co., Ltd. (5 510(k)s)
- Zhejiang Soudon Medical Technology Co., Ltd. (5 510(k)s)
- Zhejiang Kangkang Medical-Devices Co., Ltd. (4 510(k)s)
- Zhejiang Nysin Medical Co., Ltd. (4 510(k)s)
- Zhejiang Gongdong Medical Technology Co., Ltd. (3 510(k)s)
- Zhejiang Zhonglei Medical Technology Co. , Ltd. (3 510(k)s)
- Zhejiang Carebao Co., Ltd. (2 510(k)s)
- Zhejiang Geyi Medical Instrument Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zhejiang Kindly Medical Devices Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Zhejiang Kindly Medical Devices Co., Ltd.” (first 2018, latest 2022), across 3 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 Zhejiang Kindly Medical Devices Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zhejiang Kindly Medical Devices Co., Ltd. is 226 days. Since 2017: 226 days, versus 180 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zhejiang Kindly Medical Devices Co., Ltd.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 3); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 1); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 1).
Next steps
- See all 5 Zhejiang Kindly Medical Devices Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Zhejiang Kindly Medical Devices 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.