STERRAD 50 STERILIZER
FDA 510(k) clearance K981625 · decided 1999-01-11
Clearance details
- K-number
- K981625
- Device name
- STERRAD 50 STERILIZER
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 1998-05-07
- Decision date
- 1999-01-11
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- MLR
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used recall (Z-1570-2009) | Advanced Sterilization Products | 2009-06-30 |
| STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is a l recall (Z-1419-2009) | Advanced Sterilization Products | 2009-06-15 |
| STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture se recall (Z-1629-2008) | Advanced Sterilization Products | 2008-08-08 |
| STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA recall (Z-0845-2008) | Advanced Sterilization Products | 2008-02-08 |
| STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for U recall (Z-0844-2008) | Advanced Sterilization Products | 2008-02-07 |