FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDPOINT 500 PERACETIC ACID TEST INDICATORS
K Number: K931935
·
Decision Feb 7, 1994
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
33
Review Days
294
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
- ENDPOINT 500 PERACETIC ACID TEST INDICATORS
- K Number
- K931935
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Minntech Corp.
- Date Received
- April 19, 1993
- Decision Date
- February 7, 1994
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOJ), ordered by most recent decision date.
LF Process Indicator Tape for Steam Sterilization
FDA 510(k)
FDA Class 2
·General Hospital
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
FDA 510(k)
FDA Class 2
·General Hospital
DISINTEK PA Test Strips
FDA 510(k)
FDA Class 2
·General Hospital
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
FDA 510(k)
FDA Class 2
·General Hospital
VERIFY STEAM Integrating Indicator
FDA 510(k)
FDA Class 2
·General Hospital
Green Card Bowie-Dick Test (BD115)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Minntech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K120306 | RAPICIDE OPA-28 | Sep 27, 2012 | Substantially Equivalent |
| K092387 | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM | Apr 5, 2010 | Substantially Equivalent |
| K071298 | HF JUNIOR HEMOFILTER | Aug 8, 2007 | Substantially Equivalent |
| K050952 | HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR | Jan 31, 2006 | Substantially Equivalent |
| K033505 | RENACLEAN SH DIALYZER CLEANING SYSTEM | Apr 27, 2004 | Substantially Equivalent |
| K014016 | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER | Feb 1, 2002 | Substantially Equivalent |
| K991137 | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER | Jun 8, 2000 | Substantially Equivalent |
| K000028 | RENAFLO II HF 2000 HEMOFILTER | Apr 4, 2000 | Substantially Equivalent |
| K991851 | RENACLEAR DIALYZER CLEANING SYSTEM | Aug 30, 1999 | Substantially Equivalent |
| K983126 | FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS | Mar 8, 1999 | Substantially Equivalent |