510(k) · Cleared
ClearedRaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rayner Intraocular Lenses, Ltd. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Dec 18, 2014 as substantially equivalent to K132002 (Rayner Intraocular Lenses, Ltd., 2014) after a 30-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Dec 18, 2014
- Review
- 30 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K914311 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK914311 Chiroflex II Lens Microsert (TM)Chiron Ophthalmics · 1992
- 5 generations backK970727 Mport Foldable Lens Placement SystemChiron Vision Corp. · 1997 · Recalled
- 4 generations backK052651 C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006
- 3 generations backK062612 Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006
- 2 generations backK091507 Rayner Small Incision Single Use Soft Tipped Injector, Model…Rayner Intraocular Lenses, Ltd. · 2009
- 1 generation backK132002 Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft…Rayner Intraocular Lenses, Ltd. · 2014
- This deviceK143307 RaySert PLUS Injector, Single Use Soft Tipped Disposable InjectorRayner Intraocular Lenses, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914311 | Chiroflex II Lens Microsert (TM) | Chiron Ophthalmics | 1992 | — |
| −5 | K970727 | Mport Foldable Lens Placement System | Chiron Vision Corp. | 1997 | 1 |
| −4 | K052651 | C-Flex System Single Use Disposable Injector, Model R-Inj-02 | Rayner Surgical, Inc. | 2006 | — |
| −3 | K062612 | Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04 | Rayner Surgical, Inc. | 2006 | — |
| −2 | K091507 | Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18 | Rayner Intraocular Lenses, Ltd. | 2009 | — |
| −1 | K132002 | Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped… | Rayner Intraocular Lenses, Ltd. | 2014 | — |
| 0 (this device) | K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | Rayner Intraocular Lenses, Ltd. | 2014 | — |
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 |
|---|---|---|---|
| * | K132002 | Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped Small…Summary page 5…=== Comparison of Devices Please see the table below for a comparison of the subject device to the predicates. Characteristic Predicate K132002 Subject Devices (Model R-INJ-04) (Mod… | 2014 |
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 22 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K132002.
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. 2014, 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 Rayner Injectors (Models STWO01 and RSP01) are intended to be used to compress and insert into the capsular bag
only those intraocular lenses that allow the use of these injectors in their approved labeling.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143307: RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143307
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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