# K091507: Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18

- Pathway: 510(k) (Traditional)
- Applicant: Rayner Intraocular Lenses, Ltd.
- Decided: Dec 4, 2009 after 197 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.
3 later devices descend from it; 1 cites it directly.
0 of 8 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”.

## Most influential descendants
- 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

## Indications for use
"The disposable single use soft tipped small incision injector (model number R-INJ-04/18) is intended to be used to compress and insert into the capsular bag only those JOL models that allow use of this injector in their approved labelling." Federal U.S. Law restricts this device to sale by, or on the order of a physician.

Source page: https://510kreport.com/device/K091507
Methodology: https://510kreport.com/methodology