FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIVER VIAL ADAPTER
K Number: K933335
·
Decision Mar 1, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
16
Review Days
236
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
- RIVER VIAL ADAPTER
- K Number
- K933335
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- River Medical, Inc.
- Date Received
- July 8, 1993
- Decision Date
- March 1, 1994
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMF), ordered by most recent decision date.
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
FDA 510(k)
FDA Class 2
·General Hospital
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Instylla Delivery Kit
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by River Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023174 | DISPOSABLE TEMPORARY PACING WIRE | Jun 11, 2003 | Substantially Equivalent |
| K944351 | SMARTDOSE IV PREFILLED INFUSION CONTAINER | Nov 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K944352 | SMARTDOSE III INFUSION CONTAINER | Nov 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K945298 | SMARTFLOW I ADMINISTRATION SET | Jun 14, 1995 | Substantially Equivalent |
| K943692 | SMART DOSE(TM) | Apr 28, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K932895 | RIVER PUMP | Mar 31, 1994 | Substantially Equivalent |
| K915120 | TEF/PLATINUM PISTON | Dec 27, 1991 | Substantially Equivalent |
| K915121 | TEF/WIRE PISTON | Dec 23, 1991 | Substantially Equivalent |
| K913287 | H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET | Dec 18, 1991 | Substantially Equivalent |
| K913285 | PTFE PISTON | Dec 18, 1991 | Substantially Equivalent |