FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAP, TAMPER PROOF PLASTIC
K Number: K782113
·
Decision Jun 1, 1979
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
17
Review Days
164
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
- CAP, TAMPER PROOF PLASTIC
- K Number
- K782113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Acacia, Inc.
- Date Received
- December 19, 1978
- Decision Date
- June 1, 1979
- Product Code
- KPE
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPE), ordered by most recent decision date.
Disposable Infusion Bag for Parenteral Nutrition
FDA 510(k)
FDA Class 2
·General Hospital
ClaveQS Bag
FDA 510(k)
FDA Class 2
·General Hospital
KabiHelp® Uno; KabiHelp® Advance plus
FDA 510(k)
FDA Class 2
·General Hospital
eZSURE Empty Fluid Container
FDA 510(k)
FDA Class 2
·General Hospital
DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
FDA 510(k)
FDA Class 2
·General Hospital
eZSURE Empty Fluid Container with ProSeal Injection Site
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Acacia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | Sep 19, 2014 | Substantially Equivalent |
| K122449 | ENTERAL NUTRITION WARMER | Jun 13, 2013 | Substantially Equivalent |
| K111381 | MEDI-SIS SYRINGE INFUSION SYSTEM | Jan 13, 2012 | Substantially Equivalent |
| K103165 | BLOOD SAMPLING SET | Nov 10, 2010 | Substantially Equivalent |
| K092986 | ACACIA PISTON SYRINGE | Oct 27, 2009 | Substantially Equivalent |
| K972538 | FLOW-EZE BLUNT CANNULA (1999BC) | Jul 15, 1998 | Substantially Equivalent |
| K931095 | SPRING LOADED SYRINGE | Sep 16, 1993 | Substantially Equivalent |
| K912771 | ACACIAS PHARM/PUMP | Feb 14, 1992 | Substantially Equivalent |
| K901063 | LUER LOCK TRANSFER PIN | Jul 6, 1990 | Substantially Equivalent |
| K896990 | PHARMULATOR | Mar 23, 1990 | Substantially Equivalent |