FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
K Number: K012404
·
Decision Oct 12, 2001
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
83
Applicant Total
26
Review Days
74
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-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
- K Number
- K012404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5550
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Katecho, Inc.
- Date Received
- July 30, 2001
- Decision Date
- October 12, 2001
- Product Code
- DRO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRO), ordered by most recent decision date.
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
FDA 510(k)
FDA Class 2
·Cardiovascular
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
FDA 510(k)
FDA Class 2
·Cardiovascular
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTABLE INTENSIVE CARE UNIT
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOSERV P
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Katecho, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010543 | KM-30 TENS ELECTRODE | May 23, 2001 | Substantially Equivalent |
| K003228 | K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A | Dec 14, 2000 | Substantially Equivalent |
| K002806 | K-DEFIB/PACE, MODEL KDP-60A | Nov 21, 2000 | Substantially Equivalent |
| K000870 | KM-10 TENS ELECTRODE | Nov 7, 2000 | Substantially Equivalent |
| K993745 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 | Feb 3, 2000 | Substantially Equivalent |
| K991007 | K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 | Aug 23, 1999 | Substantially Equivalent |
| K981737 | K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 | Dec 9, 1998 | Substantially Equivalent |
| K954504 | K-DEFIB/PACE PEDIATRIC ELECTRODE | Nov 17, 1995 | Substantially Equivalent |
| K934692 | K-DEFIB/PACE PEDIATRIC ELECTRODE | Jan 24, 1995 | Substantially Equivalent |
| K940801 | K-KLIP | Aug 3, 1994 | Substantially Equivalent |