510(k) · Cleared
ClearedSterils Single-Use I/a Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · HQC Unit, Phacofragmentation
Cleared on Mar 12, 2008 as substantially equivalent to K951463 (Storz Instrument Co., 1995) and 1 other predicate after a 138-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Mar 12, 2008
- Review
- 138 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912739 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912739 Site 90 Tip, I/a Handpiece .3MM Side Open/Opth UseSite Microsurgical Systems, Inc. · 1991
- This deviceK073023 Sterils Single-Use I/a HandpiecesBausch & Lomb, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912739 | Site 90 Tip, I/a Handpiece .3MM Side Open/Opth Use | Site Microsurgical Systems, Inc. | 1991 | — |
| 0 (this device) | K073023 | Sterils Single-Use I/a Handpieces | Bausch & Lomb, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 HQC? 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 HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 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 |
|---|---|---|---|
| * | K951463 | Storz I/a HandpiecesSummary page 2…ge 2 of 5 510(k) Summary: Sterile Single-Use I/A Handpieces 4. Substantial Equivalence 51g(k) Clearance Date Device Description K951463 10/27/1995 Storz I/A Handpieces B&L K912739 4/7/2006… | 1995 |
| * | K912739 | Site 90 Tip, I/a Handpiece .3MM Side Open/Opth UseSummary page 2…51g(k) Clearance Date Device Description K951463 10/27/1995 Storz I/A Handpieces B&L K912739 4/7/2006 SITE Microsurncal System A comparison of characteristics of the Bausch & Lo… | 1991 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, 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 | 0 | — | 0 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The Bausch & LombTM Sterile Single-Use I/A Handpieces are used following phacoemulsification, an anterior surgical procedure to fragment and remove a cataractous lens. The eye is infused with Balanced Salt Solution (BSS) via the irrigation function, while the cortical material, viscoelastic, and excess BSS is removed via the aspiration function. I/A handpieces are also used for polishing the capsular bag to remove residual lens epithelial cells from the capsular membrane following extraction of the lens material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073023: Sterils Single-Use I/a Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073023
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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