FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
K Number: K032147
·
Decision Jul 25, 2003
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
16
Review Days
11
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
- SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
- K Number
- K032147
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alaris Medical Systems, Inc.
- Date Received
- July 14, 2003
- Decision Date
- July 25, 2003
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRN), ordered by most recent decision date.
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
FDA 510(k)
FDA Class 2
·General Hospital
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
FDA 510(k)
FDA Class 2
·General Hospital
SIGMA Spectrum Infusion Pump with Master Drug Library
FDA 510(k)
FDA Class 2
·General Hospital
MRidium 3870 MRI Infusion Pump System (3870)
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Infusion System with Guardrails Suite MX
FDA 510(k)
FDA Class 2
·General Hospital
Plum Solo Precision IV Pump
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Alaris Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K043299 | MEDLEY PCA MODULE, MODEL 8120 | Dec 10, 2004 | Substantially Equivalent |
| K041241 | MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 | Jul 6, 2004 | Substantially Equivalent |
| K031741 | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 | Feb 9, 2004 | Substantially Equivalent |
| K032233 | MEDLEY PCA MODULE, MODEL 8120 | Sep 9, 2003 | Substantially Equivalent |
| K030459 | MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) | Apr 4, 2003 | Substantially Equivalent |
| K023264 | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 | Dec 19, 2002 | Substantially Equivalent |
| K022677 | MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE | Sep 11, 2002 | Substantially Equivalent |
| K022209 | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS | Aug 6, 2002 | Substantially Equivalent |
| K013087 | SINGLE DOSE DISPENSING PIN, MODEL 2201 | Nov 13, 2001 | Substantially Equivalent |
| K012383 | GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C | Oct 2, 2001 | Substantially Equivalent |