510(k) · Cleared
ClearedStorz DP4210 Venturi Economy Anterior Pack and DP5000 Asc Daypack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Instrument Co. · MSR Tubing, Replacement, Phacofragmentation Unit
Cleared on Jun 1, 1998 as substantially equivalent to K882240 (Storz Instrument Co., 1988) and 1 other predicate after a 140-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Jun 1, 1998
- Review
- 140 days
- Class
- Class II
- Product code
- MSR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K882240 (1988). 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 deviceK980100 Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc DaypackStorz Instrument Co. · 1998
- 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) | K980100 | Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc Daypack | Storz Instrument Co. | 1998 | — |
| +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 |
|---|---|---|
| 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 MSR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K882240 | Storz Univ Irrigat/Aspira & Phacoemulsifcation PacSummary page 2…4) 225-7365 Predicate Device: The Storz DP4210 Venturi Economy Anterior Pack is substantially equivalent to the Storz DP4210 Universal /A and Phaco Pack (K882240.) The Storz DP5000 ASC Daypack is substantially equivalent to the Storz DP4210 Universal /A and Phaco Pack (K882240) and the Stor… | 1988 |
| * | K955901 | Storz DP4310DELUXE Phaco Pack Without RefluxSummary page 2…ack (K882240.) The Storz DP5000 ASC Daypack is substantially equivalent to the Storz DP4210 Universal /A and Phaco Pack (K882240) and the Storz DP4310 Deluxe Phaco Pack (K955901.) Predicate Comparison: A chart comparing the Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack to their respect… | 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 10 years and passes through 1 company; a new generation was cleared every 7.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K990292 (Ophthalmic Consultants, Inc., 1999) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K882240.
How does its category compare?
All MSR devicesMSR Tubing, Replacement, Phacofragmentation Unit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSR
FDA has decided no MSR device since 2007.
Median 510(k) review, days · MSR
Too few MSR 510(k)s in any year since 2007 to give a median.
Recalls per year · MSR
No recall names MSR since 2007.
Adverse event reports per year · MSR
2in 2023
MAUDE reports naming product code MSR, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack contain replaceable tubings, collection cassettes, needle sleeves, and tip testers for the Storz Daisy®, PREMIERE®, and Millennium™ Ophthalmic Microsurgical Systems which are used in anterior segment 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/K980100 · printed Nov 3, 2026
Cite this page
510(k) Report. “K980100: Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc Daypack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K980100
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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