510(k) · Cleared
ClearedCrystalsert Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on May 16, 2013 as substantially equivalent to K082944 (Bausch & Lomb, Inc., 2008) after a 162-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.
- Decided
- May 16, 2013
- Review
- 162 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914311 (1992). 2 later devices descend from it, 1 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 backK082944 Crystalsert Crystalens Delivery SystemBausch & Lomb, Inc. · 2008
- This deviceK123736 Crystalsert Delivery SystemBausch & Lomb · 2013
- Descendant · cites it directly · 1 of its ownK132593 Crystalsert Delivery SystemBausch & Lomb · 2013
- Descendant · 2 generations on · 0 of its ownK173480 Crystalsert Lens Delivery SystemBausch & Lomb, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView 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 | K082944 | Crystalsert Crystalens Delivery System | Bausch & Lomb, Inc. | 2008 | — |
| 0 (this device) | K123736 | Crystalsert Delivery System | Bausch & Lomb | 2013 | — |
| +1 | K132593 | Crystalsert Delivery System | Bausch & Lomb | 2013 | — |
| +2 | K173480 | Crystalsert Lens Delivery System | Bausch & Lomb, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 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 |
|---|---|---|---|
| * | K082944 | Crystalsert Crystalens Delivery SystemSummary page 1…ecember 4, 2012 Trade name: Crystalsert Delivery System Classification Intraocular lens guide (21 CFR 886.4300) Name: Predicate K082944 Crystalsert Crystalens Delivery System Devices: Device The Crystalsert Delivery System is a sterile, single-… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132593 | Crystalsert Delivery System | 2013 | 1 |
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 21 years and passes through 4 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, K132593 (Bausch & Lomb, 2013) has gone furthest, with 1 descendant of its own.
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. 2013, 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 Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert delivery system in their approved labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123736: Crystalsert Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123736
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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