510(k) · Cleared
ClearedRayner Single Use Small Incision Disposable Injector, Model R-Inj-06
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rayner Surgical, Inc. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Sep 5, 2008 as substantially equivalent to K062612 (Rayner Surgical, Inc., 2006) after a 105-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Sep 5, 2008
- Review
- 105 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K914311 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK914311 Chiroflex II Lens Microsert (TM)Chiron Ophthalmics · 1992
- 3 generations backK970727 Mport Foldable Lens Placement SystemChiron Vision Corp. · 1997 · Recalled
- 2 generations backK052651 C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006
- 1 generation backK062612 Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006
- This deviceK081455 Rayner Single Use Small Incision Disposable Injector, Model R-Inj-06Rayner Surgical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914311 | Chiroflex II Lens Microsert (TM) | Chiron Ophthalmics | 1992 | — |
| −3 | K970727 | Mport Foldable Lens Placement System | Chiron Vision Corp. | 1997 | 1 |
| −2 | K052651 | C-Flex System Single Use Disposable Injector, Model R-Inj-02 | Rayner Surgical, Inc. | 2006 | — |
| −1 | K062612 | Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04 | Rayner Surgical, Inc. | 2006 | — |
| 0 (this device) | K081455 | Rayner Single Use Small Incision Disposable Injector, Model R-Inj-06 | Rayner Surgical, Inc. | 2008 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSS device
- #1 K261174 RxSight® Insertion Devicescore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062612 | Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04 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”. | 2006 |
| † | K052651 | C-Flex System Single Use Disposable Injector, Model R-Inj-02 | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K062612.
How does its category compare?
All MSS devicesMSS Folders And Injectors, Intraocular Lens (Iol): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MSS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSS
54in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSS
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSS
429in 2025
MAUDE reports naming product code MSS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 445 |
| 2008 | 5 | 84 | 0 | 185 |
| 2009 | 5 | 197 | 0 | 186 |
| 2010 | 2 | — | 0 | 203 |
| 2011 | 2 | — | 0 | 95 |
| 2012 | 2 | — | 0 | 129 |
| 2013 | 5 | 141 | 0 | 203 |
| 2014 | 5 | 78 | 0 | 114 |
| 2015 | 3 | 156 | 0 | 127 |
| 2016 | 2 | — | 1 | 112 |
| 2017 | 3 | 30 | 1 | 114 |
| 2018 | 1 | — | 0 | 340 |
| 2019 | 3 | 67 | 0 | 271 |
| 2020 | 2 | — | 0 | 362 |
| 2021 | 1 | — | 0 | 289 |
| 2022 | 0 | — | 0 | 490 |
| 2023 | 3 | 54 | 0 | 330 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 1 | — | 0 | 429 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081455 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081455: Rayner Single Use Small Incision Disposable Injector, Model R-Inj-06.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081455
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026