FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Insulin Pen Needle
K Number: K221178
·
Decision Nov 17, 2022
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
7
Review Days
206
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Basic Information
- Device Name
- Disposable Insulin Pen Needle
- K Number
- K221178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ningbo Medsun Medical Co., Ltd.
- Date Received
- April 25, 2022
- Decision Date
- November 17, 2022
- 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 |
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Other Clearances by Ningbo Medsun Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253622 | Safety Pen Needle | Mar 18, 2026 | Substantially Equivalent |
| K253605 | Safety Heel Lancet | Feb 20, 2026 | Substantially Equivalent |
| K242627 | Safety Lancet | Oct 30, 2024 | Substantially Equivalent |
| K242316 | Safety Lancet | Aug 28, 2024 | Substantially Equivalent |
| K232330 | Lancing System | Jan 4, 2024 | Substantially Equivalent |
| K222090 | Safety Lancet | Sep 30, 2022 | Substantially Equivalent |