Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant MS10, Manzi Chemical Indicator
510(k) K060458
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060458 | Date12 Oct 2006 | 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- Withdrawn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
- FEB
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Manzi Mach 1 Instrument Cleaner-Processor System is a Cleaner-Disinfector for Bronchoscopes (FDA classification FEB), designed to clean and provide high-level disinfection of flexible bronchoscopes. It employs a proprietary push-pull agitation system to scrub both interior and exterior surfaces while using the MD10 detergent and MS10 sterilant, ensuring thorough decontamination without requiring specialized connectors.
This system is a stand-alone, reusable device intended for use in gastroenterology and urology settings. It operates with non-sterile detergent and sterilant cartridges, with the chemical indicator verifying process completion. The system is FDA 510(k)-cleared (K060458) under regulation 876.1500 and is classified as Class II. No MRI safety or single-use specifications are noted in the regulatory data.
Other devices from Langford IC Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What clinical specialties is the Manzi Mach 1 Instrument Cleaner-Processor System primarily intended for in clinical practice?
The Manzi Mach 1 is designed for use in gastroenterology and urology settings, where it cleans and provides high-level disinfection of flexible bronchoscopes. This is supported by its FDA classification under product code FEB (Cleaner-Disinfector for Bronchoscopes) and its advisory committee designation for these specialties.
How is the Manzi Mach 1 system supplied, and are the detergent and sterilant cartridges single-use or reusable?
The system is a stand-alone, reusable machine, while the detergent (MD10) and sterilant (MS10) are supplied in non-sterile, disposable cartridges. This setup ensures each cleaning/disinfection cycle uses fresh chemicals, reducing cross-contamination risk between procedures.
Does the Manzi Mach 1 include any verification that the cleaning and disinfection process was completed successfully?
Yes, the system incorporates a Manzi Chemical Indicator that visually confirms process completion. This indicator ensures users can verify the high-level disinfection cycle was fully executed before bronchoscopes are reused.
What type of regulatory clearance does the Manzi Mach 1 hold, and how does this affect its use in clinical environments?
The Manzi Mach 1 received FDA 510(k) clearance (K060458) under regulation 876.1500, classifying it as a Class II device. This clearance confirms it meets FDA standards for cleaning and disinfecting bronchoscopes in gastroenterology and urology settings, ensuring compliance with U.S. medical device regulations.
Are there any special storage requirements for the Manzi Mach 1 Instrument Cleaner-Processor System or its associated cartridges?
While the device itself is reusable and designed for repeated use, the detergent (MD10) and sterilant (MS10) cartridges should be stored according to manufacturer guidelines—typically in a cool, dry place away from direct sunlight. The system’s reusable components should be cleaned and maintained per the manufacturer’s instructions to ensure optimal performance and longevity.