# K955455: Baervelt Pars Plana Glaucoma Implant

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia Iovision, Inc.
- Decided: Feb 18, 1997 after 447 days
- Product code: KYF (Implant, Eye Valve)
- Device class: 2
- Regulation: 21 CFR 886.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Baerveldt Glaucoma Implant: named in the summary without a submission number

## Most influential descendants
- K012852: EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions (2002), 3 descendants of its own
- K161457: XEN Glaucoma Treatment System (2016), 1 descendant of its own
- K220032: iStent infinite Trabecular Micro-Bypass System, Model iS3 (2022), 0 descendants of its own
- K182518: AHMED ClearPath Glaucoma Drainage Device (2019), 0 descendants of its own
- K030350: Express Mini Glaucoma Shunt (2003), 0 descendants of its own

## Indications for use
The Baerveldt Pars Plana Glaucoma Implant is intended for use in patients with medically uncontrollable glaucoma with poor surgical prognosis.

Source page: https://510kreport.com/device/K955455
Methodology: https://510kreport.com/methodology