510(k) · Cleared
ClearedRayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04
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 Dec 13, 2006 as substantially equivalent to K052651 (Rayner Surgical, Inc., 2006) after a 99-day review. Its family tree reaches back 3 generations to 1992. 5 later devices descend from it.
- Decided
- Dec 13, 2006
- Review
- 99 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914311 (1992). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK914311 Chiroflex II Lens Microsert (TM)Chiron Ophthalmics · 1992
- 2 generations backK970727 Mport Foldable Lens Placement SystemChiron Vision Corp. · 1997 · Recalled
- 1 generation backK052651 C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006
- This deviceK062612 Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK091507 Rayner Small Incision Single Use Soft Tipped Injector, Model…Rayner Intraocular Lenses, Ltd. · 2009
- Descendant · 2 generations on · 2 of its ownK132002 Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft…Rayner Intraocular Lenses, Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK143307 RaySert PLUS Injector, Single Use Soft Tipped Disposable InjectorRayner Intraocular Lenses, Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK141091 Raysert Plus InjectorRayner Intraocular Lenses, Ltd. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK081455 Rayner Single Use Small Incision Disposable Injector, Model R-Inj-06Rayner Surgical, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K091507Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18Rayner Intraocular Lenses, Ltd. · 2009 · cites it directly3descendants
- K132002Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped Small…Rayner Intraocular Lenses, Ltd. · 2014 · 2 generations on2descendants
- K143307RaySert PLUS Injector, Single Use Soft Tipped Disposable InjectorRayner Intraocular Lenses, Ltd. · 2014 · 3 generations on0descendants
- K141091Raysert Plus InjectorRayner Intraocular Lenses, Ltd. · 2014 · 3 generations on0descendants
- K081455Rayner Single Use Small Incision Disposable Injector, Model R-Inj-06Rayner Surgical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914311 | Chiroflex II Lens Microsert (TM) | Chiron Ophthalmics | 1992 | — |
| −2 | K970727 | Mport Foldable Lens Placement System | Chiron Vision Corp. | 1997 | 1 |
| −1 | K052651 | C-Flex System Single Use Disposable Injector, Model R-Inj-02 | Rayner Surgical, Inc. | 2006 | — |
| 0 (this device) | K062612 | Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04 | Rayner Surgical, Inc. | 2006 | — |
| +1 | K091507 | Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18 | Rayner Intraocular Lenses, Ltd. | 2009 | — |
| +2 | K132002 | Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped… | Rayner Intraocular Lenses, Ltd. | 2014 | — |
| +3 | K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | Rayner Intraocular Lenses, Ltd. | 2014 | — |
| +3 | K141091 | Raysert Plus Injector | Rayner Intraocular Lenses, Ltd. | 2014 | 1 |
| +1 | K081455 | Rayner Single Use Small Incision Disposable Injector, Model R-Inj-06 | Rayner Surgical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 3 | 0 |
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 |
|---|---|---|---|
| * | K052651 | C-Flex System Single Use Disposable Injector, Model R-Inj-02Summary page 1…aocular lens guide. Device class is Class I. Classification Panel is Ophthalmic Information on devices to which substantial equivalence is claimed * 510(k) Number: K052651 * Trade or Proprietary or Model Name: Rayner Single Use Disposable Injector R-INJ-02 * Manufacturer: Rayner Intraocular Lense… | 2006 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K091507 (Rayner Intraocular Lenses, Ltd., 2009) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K052651.
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.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062612: Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062612
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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