510(k) · Cleared
ClearedStorz DP4310DELUXE Phaco Pack Without Reflux
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Instrument Co. · HQC Unit, Phacofragmentation
Cleared on Mar 28, 1996 as substantially equivalent to K882240 (Storz Instrument Co., 1988) after a 90-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it.
- Decided
- Mar 28, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K882240 (1988). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK882240 Storz Univ Irrigat/Aspira & Phacoemulsifcation PacStorz Instrument Co. · 1988
- This deviceK955901 Storz DP4310DELUXE Phaco Pack Without RefluxStorz Instrument Co. · 1996
- Descendant · cites it directly · 1 of its ownK980100 Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc DaypackStorz Instrument Co. · 1998
- Descendant · cites it directly · 1 of its ownK961831 Storz DP5200 Irrigation Addministration Set PackStorz Instrument Co. · 1996
- Descendant · cites it directly · 0 of its ownK033653 Venturi Phaco PackBausch & Lomb, Inc. · 2003 · Recalled
- Descendant · cites it directly · 0 of its ownK990292 I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior…Ophthalmic Consultants, Inc. · 1999
Most influential descendants
Showing 4 of 4 · See all- K980100Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc DaypackStorz Instrument Co. · 1998 · cites it directly1descendant
- K961831Storz DP5200 Irrigation Addministration Set PackStorz Instrument Co. · 1996 · cites it directly1descendant
- K033653Venturi Phaco PackBausch & Lomb, Inc. · 2003 · cites it directly0descendants
- K990292I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack…Ophthalmic Consultants, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882240 | Storz Univ Irrigat/Aspira & Phacoemulsifcation Pac | Storz Instrument Co. | 1988 | — |
| 0 (this device) | K955901 | Storz DP4310DELUXE Phaco Pack Without Reflux | Storz Instrument Co. | 1996 | — |
| +1 | K980100 | Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc Daypack | Storz Instrument Co. | 1998 | — |
| +1 | K961831 | Storz DP5200 Irrigation Addministration Set Pack | Storz Instrument Co. | 1996 | — |
| +1 | K033653 | Venturi Phaco Pack | Bausch & Lomb, Inc. | 2003 | 3 |
| +1 | K990292 | I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy… | Ophthalmic Consultants, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K882240 | Storz Univ Irrigat/Aspira & Phacoemulsifcation PacSummary page 1…926) with the above Storz microsurgical systems. Predicate Device: The Storz DP4310 is substantially equivalent to the Storz Universal I/A and Phacoemulsification Pack (K882240). } Predicate Comparison: A chart comparing the Storz DP4310 Deluxe Phaco Pack STORZ 3365 Tree (ot industrial Bivd., StoLows,… | 1988 |
What descends from it? (4)
4 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?
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Irrigation/Aspiration and Phacoemulsification
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955901: Storz DP4310DELUXE Phaco Pack Without Reflux.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955901
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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