510(k) · Cleared
ClearedStorz DP5200 Irrigation Addministration Set Pack
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 Aug 6, 1996 as substantially equivalent to K894278 (Storz Instrument Co., 1989) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Aug 6, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K882240 (1988). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK882240 Storz Univ Irrigat/Aspira & Phacoemulsifcation PacStorz Instrument Co. · 1988
- 1 generation backK955901 Storz DP4310DELUXE Phaco Pack Without RefluxStorz Instrument Co. · 1996
- This deviceK961831 Storz DP5200 Irrigation Addministration Set PackStorz Instrument Co. · 1996
- 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K882240 | Storz Univ Irrigat/Aspira & Phacoemulsifcation Pac | Storz Instrument Co. | 1988 | — |
| −1 | K955901 | Storz DP4310DELUXE Phaco Pack Without Reflux | Storz Instrument Co. | 1996 | — |
| 0 (this device) | K961831 | Storz DP5200 Irrigation Addministration Set Pack | Storz Instrument Co. | 1996 | — |
| +1 | K990292 | I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy… | Ophthalmic Consultants, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (3)
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 |
|---|---|---|---|
| * | K894278 | Storz Daisyplus Series Microsurgical SystemsSummary page 1…ription/intended Use: The Storz DP5200 is intended to be used as an accessory to the Storz DAISY ® (K854508), Storz Protegé ® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir, to the surg… | 1989 |
| * | K921758 | Storz Protege Opthalmic Microsurgical SystemSummary page 1…Phacofragmentation (86 HQC). Device Description/intended Use: The Storz DP5200 is intended to be used as an accessory to the Storz DAISY ® (K854508), Storz Protegé ® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid… | 1992 |
| * | K955901 | Storz DP4310DELUXE Phaco Pack Without RefluxSummary page 1…equivalent to the Storz existing DP5200 Ambulatory Surgery Center (ASC) Irrigation Administration Set Pack (K894278, K921758) and to the Storz DP4310 Deluxe Phaco Pack (K955901). Predicate Comparison: A chart comparing the Storz DP5200 to the predicate devices, demonstrating substantial equivalence, is a… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990292 | I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack… | 1999 | 0 |
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 8 years and passes through 1 company; a new generation was cleared every 7.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K990292 (Ophthalmic Consultants, Inc., 1999) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K894278.
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?
The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir, to the surgical handpiece irrigation line, during ophthalmic surgical procedures.
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/K961831 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961831: Storz DP5200 Irrigation Addministration Set Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961831
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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