# K971795: Automated Chamber Maintenance Module

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Medical Industries, Inc.
- Decided: Jul 14, 1997 after 60 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K020734: Surge-Free Aspiration Adapter (2002), 1 descendant of its own
- K050648: Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack (2005), 0 descendants of its own

## Indications for use
The ACM Module is an accessory device incorporated in the aspiration line behind the handpiece to neutralize vacuum surge during phacoemulsification.

Source page: https://510kreport.com/device/K971795
Methodology: https://510kreport.com/methodology