FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAL Infiltration System
K Number: K220318
·
Decision Oct 14, 2022
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
57
Applicant Total
9
Review Days
253
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
- PAL Infiltration System
- K Number
- K220318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microaire Surgical Instruments, LLC
- Date Received
- February 3, 2022
- Decision Date
- October 14, 2022
- Product Code
- QPB
- 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 |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QPB), ordered by most recent decision date.
Lipocosm Harmonic System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AYON Body Contouring System (AYON SYSTEM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LSSA (NP-200)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AYON Body Contouring System (AYON SYSTEM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PAL 7020 Console
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PAL Aspiration System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Microaire Surgical Instruments, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K243589 | PAL Sterilization Case | Jun 20, 2025 | Substantially Equivalent |
| K244026 | PAL 7020 Console | Apr 25, 2025 | Substantially Equivalent |
| K242804 | PAL Aspiration System | Dec 30, 2024 | Substantially Equivalent |
| K212024 | PAL System | Jun 10, 2022 | Substantially Equivalent |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | Nov 6, 2018 | Substantially Equivalent |
| K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | Oct 13, 2017 | Substantially Equivalent |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | May 22, 2015 | Substantially Equivalent |
| K113128 | MICROAIRE SURGICAL INSTRUMENTS LLC | Aug 17, 2012 | Substantially Equivalent |