# K101158: Lic Instrument Processing System

- Pathway: 510(k) (Traditional)
- Applicant: Langford IC Systems, Inc.
- Decided: May 6, 2011 after 375 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: 3 generations back to K983017 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060458: Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant MS10, Manzi Chemical Indicator, Langford IC Systems, Inc. (2006) Summary page 1.

## Indications for use
The LIC Instrument Processing System consists of the LIC Instrument Processor, the Manzi Detergent MD10, the Manzi Sterilant MS10, and filtered ozonated final rinse water. The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the LIC Instrument Processor. The Manzi Detergent MD10 concentrate when used with the LIC Instrument Processor is indicated for the cleaning of heat sensitive semi-critical endoscopes used in health care settings by health care workers. The Manzi Sterilant MS10 concentrate when used in the LIC Instrument Processor is indicated for high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

Source page: https://510kreport.com/device/K101158
Methodology: https://510kreport.com/methodology