# K012108: Medpor Coated Tear Drain

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Dec 19, 2001 after 166 days
- Product code: OKS (Lacrimal Stents And Intubation Sets)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) MEDPOR® Surgical Implant Material: named in the summary without a submission number
- (no number) Pre-amendment borosilicate glass Jones tube: named in the summary without a submission number

## Indications for use
An implant to bypass the obstructed lacrimal drainage system for the treatment of chronic epiphora.

Source page: https://510kreport.com/device/K012108
Methodology: https://510kreport.com/methodology