FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING
K Number: K100720
·
Decision Nov 18, 2010
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
11
Review Days
248
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
- K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING
- K Number
- K100720
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kawasumi Laboratories, Inc.
- Date Received
- March 15, 2010
- Decision Date
- November 18, 2010
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.
iiSure Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
FDA 510(k)
FDA Class 2
·General Hospital
PuraCath Firefly Needleless Connector IT (9005)
FDA 510(k)
FDA Class 2
·General Hospital
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Pump Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
EZ IV Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Kawasumi Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | Jul 8, 2019 | Substantially Equivalent |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) | May 2, 2019 | Substantially Equivalent |
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Sep 28, 2018 | Substantially Equivalent |
| K123344 | K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) | Mar 7, 2013 | Substantially Equivalent |
| K102994 | K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR | Nov 3, 2010 | Substantially Equivalent |
| K073257 | KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR | Jan 25, 2008 | Substantially Equivalent |
| K061197 | KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER | Jun 30, 2006 | Substantially Equivalent |
| K060580 | K-SHIELD PORT ACCESS INFUSION SET | Jun 6, 2006 | Substantially Equivalent |
| K023917 | WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR | Feb 26, 2003 | Substantially Equivalent |
| K022110 | KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. | Sep 12, 2002 | Substantially Equivalent |