# K062612: Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04

- Pathway: 510(k) (Traditional)
- Applicant: Rayner Surgical, Inc.
- Decided: Dec 13, 2006 after 99 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- Device class: 1
- Regulation: 21 CFR 886.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914311 (1992). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052651: C-Flex System Single Use Disposable Injector, Model R-Inj-02, Rayner Surgical, Inc. (2006) Summary page 1.

## Most influential descendants
- K091507: Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18 (2009), 3 descendants of its own
- K132002: Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped Small Incision Disposable Injector (2014), 2 descendants of its own
- K143307: RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (2014), 0 descendants of its own
- K141091: Raysert Plus Injector (2014), 0 descendants of its own
- K081455: Rayner Single Use Small Incision Disposable Injector, Model R-Inj-06 (2008), 0 descendants of its own

## Indications for use
The disposable single-use, soft tipped injector (model number R-INJ-04) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.

Source page: https://510kreport.com/device/K062612
Methodology: https://510kreport.com/methodology