# K062252: MOLTENO3

- Pathway: 510(k) (Traditional)
- Applicant: Iop, Inc.
- Decided: Sep 27, 2006 after 55 days
- Product code: KYF (Implant, Eye Valve)
- Device class: 2
- Regulation: 21 CFR 886.3920
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Molteno Implant devices: named in the summary without a submission number

## Most influential descendants
- K152996: Molteno3 Glaucoma Implant (2015), 0 descendants of its own

## Recalls of this device
- Feb 22, 2016 · Class II · Z-1252-2016: Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement to mi

## Indications for use
The Molteno3 glaucoma implants is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have not been successful to control the progression of disease.

Source page: https://510kreport.com/device/K062252
Methodology: https://510kreport.com/methodology