FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
K Number: K202319
·
Decision Nov 12, 2021
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
12
Review Days
452
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
- Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
- K Number
- K202319
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tianjin Huahong Technology Co., Ltd.
- Date Received
- August 17, 2020
- Decision Date
- November 12, 2021
- 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 Tianjin Huahong Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260191 | Safety lancet (XXXVII) | Mar 31, 2026 | Substantially Equivalent |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Feb 12, 2026 | Substantially Equivalent |
| K253706 | Lancing device (HH-XV-T) | Dec 9, 2025 | Substantially Equivalent |
| K251694 | safety lancet | Jun 26, 2025 | Substantially Equivalent |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) | Nov 15, 2024 | Substantially Equivalent |
| K241627 | Safety Lancet (XXXV) | Jun 20, 2024 | Substantially Equivalent |
| K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) | May 21, 2024 | Substantially Equivalent |
| K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | Jul 6, 2022 | Substantially Equivalent |
| K221176 | Insulin Pen Needle | Jul 1, 2022 | Substantially Equivalent |
| K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) | May 19, 2022 | Substantially Equivalent |