Zhejiang Kindly Medical Devices Co., Ltd.
WENZHOU Zhejiang, CN
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD appears in FDA device records in WENZHOU Zhejiang, CN. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Zhejiang Kindly Medical Devices Co., Ltd. between 2018 and 2022. The busiest year on record is 2018, with 3. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 3 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223334 | Sterile Hypodermic Needles for Single Use | FMI | Substantially Equivalent | |
| K213183 | Safety Insulin Pen Needles | FMI | Substantially Equivalent | |
| K181069 | Disposable Insulin Pen Needle | FMI | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles | BSP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615588 | 3003560965 | ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD | No.758, 5th Binhai Road Binhai Industrial Park, Longwan, WENZHOU Zhejiang 325025 CN | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCEAdaptor, Catheter
- IQGAdaptor, Holder, Syringe
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- QNSLow Dead Space Needle, Single Lumen, Hypodermic
- QNQLow Dead Space Piston Syringe
- GAANeedle, Aspiration And Injection, Disposable
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FMINeedle, Hypodermic, Single Lumen
- QYMOphthalmic Needle
- QLYOphthalmic Syringe
- PORParenteral Administration Kit
- FPASet, Administration, Intravascular
- MEGSyringe, Antistick
- FMFSyringe, Piston
- KSTSystem, Blood Collection, Vacuum-Assisted, Manual
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0209-2022 | HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm | Potential for difficulty in safety mechanism activation. | Class II | Terminated | |
| Z-0208-2022 | HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm | Potential for difficulty in safety mechanism activation. | Class II | Terminated | |
| Z-0207-2022 | McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS | Potential for difficulty in safety mechanism activation. | Class II | Terminated | |
| Z-0206-2022 | McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS | Potential for difficulty in safety mechanism activation. | Class II | Terminated | |
| Z-0205-2022 | McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS | Potential for difficulty in safety mechanism activation. | Class II | Terminated | |
| Z-0204-2022 | McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS | Potential for difficulty in safety mechanism activation. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain