510(k) · Cleared
ClearedBausch & Lomb Injector 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 Jan 9, 2014 as substantially equivalent to K113852 (Bausch & Lomb, Inc., 2012) and 1 other predicate after a 196-day review. Its family tree reaches back 6 generations to 1994. 9 later devices descend from it.
- Decided
- Jan 9, 2014
- Review
- 196 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K930320 (1994). 10 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 5 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 4 generations backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- 3 generations backK070669 Iol Injector SetMedicel AG · 2007 · Recalled
- 2 generations backK092023 Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
- 1 generation backK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
- This deviceK131958 Bausch & Lomb Injector SystemBausch & Lomb · 2014
- Descendant · cites it directly · 5 of its ownK151102 Bausch + Lomb Injector SystemBausch & Lomb, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK181401 RxSight Insertion DeviceRxsight, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK192926 RxSight Insertion DeviceRxsight, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK231466 RxSight Insertion DeviceRxsight, Inc. · 2023
- Descendant · 5 generations on · 1 of its ownK231838 RxSight® Insertion Device (63002)Rxsight, Inc. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K151102Bausch + Lomb Injector SystemBausch & Lomb, Inc. · 2015 · cites it directly5descendants
- K181401RxSight Insertion DeviceRxsight, Inc. · 2018 · 2 generations on4descendants
- K192926RxSight Insertion DeviceRxsight, Inc. · 2020 · 3 generations on3descendants
- K231466RxSight Insertion DeviceRxsight, Inc. · 2023 · 4 generations on2descendants
- K231838RxSight® Insertion Device (63002)Rxsight, Inc. · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −5 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −4 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| −3 | K070669 | Iol Injector Set | Medicel AG | 2007 | 1 |
| −2 | K092023 | Naviject SUB2-1P, Model: LP604430 | Medicel AG | 2009 | — |
| −1 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
| 0 (this device) | K131958 | Bausch & Lomb Injector System | Bausch & Lomb | 2014 | — |
| +1 | K151102 | Bausch + Lomb Injector System | Bausch & Lomb, Inc. | 2015 | — |
| +2 | K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018 | — |
| +3 | K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020 | — |
| +4 | K231466 | RxSight Insertion Device | Rxsight, Inc. | 2023 | — |
| +5 | K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K113852 | Bausch & Lomb Iol InjectorSummary page 1…Trade name: Bausch + Lomb Injector System Common Name: Intraocular lens Guide Classification Name: 21 CFR 886.4300 2. Predicate Devices: K1 13852, Bausch + Lomb lOL Injector K0631 55, Alcon Monarch Ill IOL Delivery System 3. Device Description: The Bausch + Lomb In… | 2012 |
| * | K063155 | Monarch Iii Iol Delivery SystemSummary page 1…tor System Common Name: Intraocular lens Guide Classification Name: 21 CFR 886.4300 2. Predicate Devices: K1 13852, Bausch + Lomb lOL Injector K0631 55, Alcon Monarch Ill IOL Delivery System 3. Device Description: The Bausch + Lomb Injector System is used for folding and deli… | 2007 |
What descends from it? (9)
3 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 20 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K151102 (Bausch & Lomb, Inc., 2015) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K113852.
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 BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131958: Bausch & Lomb Injector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131958
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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