FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Multi-Lancet Device 2, ReliOn Premier Lancing Device
K Number: K221175
·
Decision Oct 17, 2022
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
23
Applicant Total
18
Review Days
175
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
- Multi-Lancet Device 2, ReliOn Premier Lancing Device
- K Number
- K221175
- 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
- Arkray, Inc.
- Date Received
- April 25, 2022
- Decision Date
- October 17, 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 Arkray, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | May 3, 2024 | Substantially Equivalent |
| K193514 | AUTION MAX AX-4060 Urinalysis System | Apr 13, 2023 | Substantially Equivalent |
| K200788 | Assure Titanium Blood Glucose Monitoring System | May 23, 2022 | Substantially Equivalent |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Oct 7, 2016 | Substantially Equivalent |
| K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL | Feb 1, 2013 | Substantially Equivalent |
| K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | Dec 23, 2009 | Substantially Equivalent |
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | Mar 24, 2006 | Substantially Equivalent |
| K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | Jan 31, 2006 | Substantially Equivalent |
| K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS | Jun 17, 2005 | Substantially Equivalent |
| K050790 | SPOTCHEM II LDH TEST | Jun 6, 2005 | Substantially Equivalent |