# K081455: Rayner Single Use Small Incision Disposable Injector, Model R-Inj-06

- Pathway: 510(k) (Traditional)
- Applicant: Rayner Surgical, Inc.
- Decided: Sep 5, 2008 after 105 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: 4 generations back to K914311 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062612: Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04, Rayner Surgical, Inc. (2006). Our reading of the summary gave K062512, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Rayner Single Use Soft Tipped Disposable Injector R-INJ-04”.

## Indications for use
The single-use small incision disposable injector (model number R-INJ-06) 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/K081455
Methodology: https://510kreport.com/methodology