SteriTec Disposable Integrator Load Challenge-Steam
by Steritec Products Mfg Co, Inc.
510(k) K965212
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK965212 | Date23 Apr 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JOJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2800
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a disposable chemical integrator used for validating the performance of physical/chemical sterilization processes, specifically steam sterilization. It functions as a process challenge device (PCD) to verify that sterilization parameters—such as temperature, pressure, and time—are met during the steam sterilization cycle. By providing a visual or chemical response, it confirms the sterilizer’s ability to achieve the required conditions for effective sterilization.
The SteriTec Disposable Integrator Load Challenge-Steam is intended for single-use in general hospital settings and is designed to supplement biological testing. It is non-sterile as supplied and must be processed through the sterilizer alongside loads to validate performance. The device is classified as Class II under FDA regulations and holds an FDA 510(k) clearance (K965212) as substantially equivalent to predicate devices. No MRI safety or reusable components are indicated in the specifications.
Other devices from Steritec Products Mfg. Co., Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the SteriTec Disposable Integrator Load Challenge-Steam used for in a hospital setting?
The SteriTec Disposable Integrator Load Challenge-Steam is a single-use chemical integrator designed to validate the performance of steam sterilization processes in hospitals. It acts as a process challenge device (PCD) to confirm that sterilizers are achieving the required temperature, pressure, and time parameters during cycles. It supplements biological testing by providing a visual or chemical response to verify sterilization effectiveness, ensuring loads meet regulatory standards.
Is this device reusable, or is it meant for one-time use after sterilization?
The SteriTec Disposable Integrator Load Challenge-Steam is explicitly single-use only. It is non-sterile as supplied and must be processed through the sterilizer alongside medical loads to validate performance. After use, it should be discarded, as reuse is not intended or supported by the manufacturer.
How should I store the SteriTec Disposable Integrator Load Challenge-Steam before use?
The device is non-sterile as supplied, meaning it does not require sterile storage conditions before processing. However, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants to preserve its integrity until use. Check the packaging for any specific shelf-life or storage instructions provided by Steritec Products.
What regulatory pathway does this device follow, and is it approved for general hospital use?
The SteriTec Disposable Integrator Load Challenge-Steam holds an FDA 510(k) clearance (K965212), classified as Class II, and is deemed substantially equivalent to predicate devices. It is specifically filed under the General Hospital advisory committee (HO) and product code (JOJ), confirming its intended use in standard hospital sterilization validation. No additional approvals beyond this clearance are mentioned in the data.