FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
LDE4 Lancing Device
K Number: K222656
·
Decision Nov 23, 2022
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
23
Applicant Total
27
Review Days
82
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Basic Information
- Device Name
- LDE4 Lancing Device
- K Number
- K222656
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- I-Sens, Inc.
- Date Received
- September 2, 2022
- Decision Date
- November 23, 2022
- Product Code
- QRL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QRL), ordered by most recent decision date.
Lancing device (HH-XV-T)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROLET®NEXT 2 Lancing Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Facet Aurora Reusable Lancet Base
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medifun Lancing Device, Model No. LD-E1
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Verifine® Ease Lancing Device, Verifine® Lancing Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by I-Sens, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | Aug 10, 2023 | Substantially Equivalent |
| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | Oct 5, 2021 | Substantially Equivalent |
| K201551 | KetoSens BT Blood B-Ketone Monitoring System | Sep 9, 2020 | Substantially Equivalent |
| K192859 | CareSens S Clear BT Blood Glucose Monitoring System | Jan 24, 2020 | Substantially Equivalent |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring System | Jan 17, 2020 | Substantially Equivalent |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring System | Dec 13, 2019 | Substantially Equivalent |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | Nov 1, 2018 | Substantially Equivalent |
| K180866 | CareSens S Fit Blood Glucose Monitoring System | Aug 31, 2018 | Substantially Equivalent |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | Apr 13, 2018 | Substantially Equivalent |
| K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System | Dec 13, 2017 | Substantially Equivalent |