510(k) Report

510(k) · Cleared

Cleared

C-Flex System Single Use Disposable Injector, Model R-Inj-02

K052651510(k) TraditionalCleared Jan 19, 2006115-day reviewClass I21 CFR 886.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rayner Surgical, Inc. · MSS Folders And Injectors, Intraocular Lens (Iol)

Cleared on Jan 19, 2006 as substantially equivalent to K970727 (Chiron Vision Corp., 1997) after a 115-day review. Its family tree reaches back 2 generations to 1992. 10 later devices descend from it.

Decided
Jan 19, 2006
Review
115 days
Class
Class I
Product code
MSS
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K914311 (1992). 10 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2006: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2014: 3 descendants cleared2017: 1 descendant cleared2015: 1 descendant clearedK914311 · Chiroflex II Lens Microsert (TM) · Chiron Ophthalmics · 1992K970727 · Mport Foldable Lens Placement System · Chiron Vision Corp. · 1997 · recalled1990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants K970727 · Mport Foldable Lens Placement System · Chiron Vision Corp. · 1997 · recalledK914311 · Chiroflex II Lens Microsert (TM) · Chiron Ophthalmics · 19920
  1. Root · 2 generations backK914311 Chiroflex II Lens Microsert (TM)Chiron Ophthalmics · 1992
  2. 1 generation backK970727 Mport Foldable Lens Placement SystemChiron Vision Corp. · 1997 · Recalled
  3. This deviceK052651 C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006
  4. Descendant · cites it directly · 5 of its ownK062612 Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006
  5. Descendant · 2 generations on · 3 of its ownK091507 Rayner Small Incision Single Use Soft Tipped Injector, Model…Rayner Intraocular Lenses, Ltd. · 2009
  6. Descendant · cites it directly · 3 of its ownK090161 Epiphany Injection SystemStaar Surgical Co. · 2009
  7. Descendant · 3 generations on · 2 of its ownK132002 Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft…Rayner Intraocular Lenses, Ltd. · 2014
  8. Descendant · 2 generations on · 2 of its ownK101782 Microstaar Msi Injector System CartridgeStaar Japan · 2010

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12009: 22010: 12014: 32015: 12017: 1
2006high 3 (2014) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • K062612Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006 · cites it directly5descendants
  • K091507Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18Rayner Intraocular Lenses, Ltd. · 2009 · 2 generations on3descendants
  • K090161Epiphany Injection SystemStaar Surgical Co. · 2009 · cites it directly3descendants
  • K132002Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped Small…Rayner Intraocular Lenses, Ltd. · 2014 · 3 generations on2descendants
  • K101782Microstaar Msi Injector System CartridgeStaar Japan · 2010 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K914311Chiroflex II Lens Microsert (TM)Chiron Ophthalmics1992—
−1K970727Mport Foldable Lens Placement SystemChiron Vision Corp.19971
0 (this device)K052651C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc.2006—
+1K062612Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc.2006—
+2K091507Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18Rayner Intraocular Lenses, Ltd.2009—
+1K090161Epiphany Injection SystemStaar Surgical Co.2009—
+3K132002Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped…Rayner Intraocular Lenses, Ltd.2014—
+2K101782Microstaar Msi Injector System CartridgeStaar Japan2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
200920
201010
201430
201510
201710
FIG. 1 — Lineage of K052651, 1992–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261174 RxSight® Insertion Devicescore 15.1 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K970727Mport Foldable Lens Placement System
Summary 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: K970727 * Trade or Proprietary or Model Name: MPORT Foldable Lens Placement System * Manufacturer Chiron Vision Corporation Inten…
Chiron Vision Corp.19971

Also cleared against K970727: 3 other devices →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062612Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc.20065
K090161Epiphany Injection SystemStaar Surgical Co.20093

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 8.1 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K062612 (Rayner Surgical, Inc., 2006) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K970727.

How does its category compare?

All MSS devices

MSS 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

2007: 22008: 52009: 52010: 22011: 22012: 22013: 52014: 52015: 32016: 22017: 32018: 12019: 32020: 22021: 12023: 32024: 12025: 12026 (partial year): 1
2007high 5 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSS

54in 2023

2008: 84 days median2009: 197 days median2013: 141 days median2014: 78 days median2015: 156 days median2017: 30 days median2019: 67 days median2023: 54 days median
2007high 197 (2009) · low 30 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MSS

1in 2017

2016: 12017: 1
2007high 1 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MSS

429in 2025

2007: 4452008: 1852009: 1862010: 2032011: 952012: 1292013: 2032014: 1142015: 1272016: 1122017: 1142018: 3402019: 2712020: 3622021: 2892022: 4902023: 3302024: 3752025: 429
2007high 490 (2022) · low 95 (2011)2025

MAUDE reports naming product code MSS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—0445
20085840185
200951970186
20102—0203
20112—095
20122—0129
201351410203
20145780114
201531560127
20162—1112
20173301114
20181—0340
20193670271
20202—0362
20211—0289
20220—0490
20233540330
20241—0375
20251—0429
20261—0—

What is it indicated for?

The disposable single-use injector (model number R-INJ-02) 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.

Also cleared against K970727

3 other devices cite the same predicate.

  • K132481Easy-Load Lens Delivery SystemBausch & Lomb · 2013
  • K090161Epiphany Injection SystemStaar Surgical Co. · 2009
  • K082944Crystalsert Crystalens Delivery SystemBausch & Lomb, Inc. · 2008

More from Rayner Surgical, Inc.

3 FDA decisions under this applicant name. See the company

  • K081455Rayner Single Use Small Incision Disposable Injector, Model R-Inj-06Rayner Surgical, Inc. · 2008
  • K062612Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006

Recent decisions in MSS

The MSS category page

  • K261174RxSight® Insertion DeviceRxsight, Inc. · 2026
  • K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG · 2025
  • K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated · 2024
  • K231106Accuject Refra Injector AR2900Medicel AG · 2023
  • K231838RxSight® Insertion Device (63002)Rxsight, Inc. · 2023

https://510kreport.com/device/K052651 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052651: C-Flex System Single Use Disposable Injector, Model R-Inj-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052651

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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