# K060458: Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant MS10, Manzi Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Langford IC Systems, Inc.
- Decided: Oct 12, 2006 after 232 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983017 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983017: Modification to System 83 Plus, Custom Ultrasonics (1998) Summary page 1.
- K043314: Manzi Cleaner System, Langford IC Systems, Inc. (2005) Summary page 1.
- K875280: Steris System 1 Processor and 20 Sterilant, Steris C/O Medical Device Consultants, Inc. (1988) Summary page 1.

## Most influential descendants
- K101158: Lic Instrument Processing System (2011), 0 descendants of its own

## Indications for use
The Manzi Mach 1 Instrument Cleaner Processor System is indicated for use with the High Level Disinfectant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers.

Source page: https://510kreport.com/device/K060458
Methodology: https://510kreport.com/methodology