FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IV START KIT
K Number: K941469
·
Decision May 12, 1994
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
29
Applicant Total
14
Review Days
45
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
- IV START KIT
- K Number
- K941469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Clinical Resources, Inc.
- Date Received
- March 28, 1994
- Decision Date
- May 12, 1994
- Product Code
- LRS
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| LRS | I.V. Start Kit | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRS), ordered by most recent decision date.
AMSINO I.V. START KIT
FDA 510(k)
FDA Class 2
·General Hospital
INFUSION IV SET
FDA 510(k)
FDA Class 2
·General Hospital
IV START KIT
FDA 510(k)
FDA Class 2
·General Hospital
EMS I.V. START KIT
FDA 510(k)
FDA Class 2
·General Hospital
B. BRAUN IV START KITS
FDA 510(k)
FDA Class 2
·General Hospital
PERSONAL HEARING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Clinical Resources, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941470 | TRACHEOSTOMY CARE KIT | Feb 14, 1995 | Unknown |
| K944882 | IRRIGATION TRAY | Jan 12, 1995 | Substantially Equivalent |
| K944881 | SKIN SCRUB TRAY | Dec 27, 1994 | Unknown |
| K944879 | GAUZE SPONGES | Dec 23, 1994 | Substantially Equivalent |
| K945021 | FLUFF GAUZE SPONGE | Dec 23, 1994 | Substantially Equivalent |
| K945019 | FLUFF GAUXZE ROLL | Dec 23, 1994 | Substantially Equivalent |
| K945020 | FLUFF GAUZE SPONGE | Dec 23, 1994 | Substantially Equivalent |
| K944880 | BODILY FLUID DISPOSAL KIT | Dec 15, 1994 | Substantially Equivalent |
| K941468 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | May 12, 1994 | Substantially Equivalent |
| K941471 | CENTRAL LINE DRESSING CHANGE TRAY | May 12, 1994 | Substantially Equivalent |