# K043314: Manzi Cleaner System

- Pathway: 510(k) (Traditional)
- Applicant: Langford IC Systems, Inc.
- Decided: Jun 20, 2005 after 201 days
- Product code: NVE (Washer, Cleaner, Automated, 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: 1 generation back to K983017 (1998). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 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 3.

## Most influential descendants
- K073112: DA Vinci Sonicpro Cleaning System, Model 400253 (2008), 5 descendants of its own
- K190081: RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (2019), 4 descendants of its own
- K200577: RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (2020), 3 descendants of its own
- K203199: RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector (2020), 2 descendants of its own
- K222543: AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System,  V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (2022), 1 descendant of its own

## Indications for use
The Manzi Cleaner, when used in accordance with its labeling and the Manzi Detergent MD10, is for the cleaning of bronchoscopes in a health care setting by health care workers.

Source page: https://510kreport.com/device/K043314
Methodology: https://510kreport.com/methodology