FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Insulin Pen Needle
K Number: K181069
·
Decision Aug 28, 2018
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
5
Review Days
127
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Disposable Insulin Pen Needle
- K Number
- K181069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zhejiang Kindly Medical Devices Co., Ltd.
- Date Received
- April 23, 2018
- Decision Date
- August 28, 2018
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMI), ordered by most recent decision date.
Profoject Safety Pen Needles
FDA 510(k)
FDA Class 2
·General Hospital
Verisafe Safety Sterile Needles (SSN)
FDA 510(k)
FDA Class 2
·General Hospital
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
PRESSONE
FDA 510(k)
FDA Class 2
·General Hospital
Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Zhejiang Kindly Medical Devices Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K223334 | Sterile Hypodermic Needles for Single Use | Dec 16, 2022 | Substantially Equivalent |
| K213183 | Safety Insulin Pen Needles | Oct 14, 2022 | 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 | Jun 4, 2018 | Substantially Equivalent |
| K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles | Jan 5, 2018 | Substantially Equivalent |