# K970095: Proclear Compatibles Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles Eyewear, Inc.
- Decided: Apr 3, 1997 after 83 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K032873: Proclear Compatibles Multifocal (2003), 10 descendants of its own
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens (2006), 9 descendants of its own
- K110099: Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft (Hydrophilic) Contact Lens; Proclear Mult (2011), 7 descendants of its own
- K112302: Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses (2011), 6 descendants of its own
- K162223: Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) (2017), 4 descendants of its own

Source page: https://510kreport.com/device/K970095
Methodology: https://510kreport.com/methodology