FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MANUAL PERCUSSOR CUPS
K Number: K883899
·
Decision Dec 13, 1988
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
57
Applicant Total
63
Review Days
89
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
- MANUAL PERCUSSOR CUPS
- K Number
- K883899
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Components, Inc.
- Date Received
- September 15, 1988
- Decision Date
- December 13, 1988
- Product Code
- BYI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BYI | Percussor, Powered-Electric | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYI), ordered by most recent decision date.
AffloVest® Mobile Airway Clearance Therapy
FDA 510(k)
FDA Class 2
·Anesthesiology
BreatheBand® (Model 1000)
FDA 510(k)
FDA Class 2
·Anesthesiology
LibAirty Airway Clearance System
FDA 510(k)
FDA Class 2
·Anesthesiology
Respiratory Muscle Trainer
FDA 510(k)
FDA Class 2
·Anesthesiology
The Vest APX System (PVAPX1)
FDA 510(k)
FDA Class 2
·Anesthesiology
Electromed SmartVest Airway Clearance System
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Medical Components, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | Aug 12, 2025 | Substantially Equivalent |
| K141633 | PRO-PICC WITH VALVE TECHNOLOGY | Sep 29, 2014 | Substantially Equivalent |
| K132880 | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE | Jan 8, 2014 | Substantially Equivalent |
| K131687 | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET | Aug 16, 2013 | Substantially Equivalent |
| K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER | Aug 15, 2013 | Substantially Equivalent |
| K130923 | 5F DIGNITY CT TITANIUM PORT | Jul 31, 2013 | Substantially Equivalent |
| K124046 | VALVED TEARAWAY INTRODUCER GENERATION II | Jun 3, 2013 | Substantially Equivalent |
| K123617 | 3F PRO-PICC | May 15, 2013 | Substantially Equivalent |
| K122423 | VASU-PICC | Dec 12, 2012 | Substantially Equivalent |
| K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | Sep 21, 2012 | Unknown |