510(k) · Cleared
ClearedStorz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic Posterior Vitrectomy Pack with Variable Port Cutter & RX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Instrument Co. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Mar 4, 1996 as substantially equivalent to K953575 (Storz Instrument Co., 1995) after a 136-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Mar 4, 1996
- Review
- 136 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953575 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK953575 Storz MVS-3201 Vitrectomy Probe PackStorz Instrument Co. · 1995
- This deviceK954816 Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic…Storz Instrument Co. · 1996
- Descendant · cites it directly · 1 of its ownK980488 Storz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co. · 1998 · Recalled
- Descendant · 2 generations on · 0 of its ownK031404 Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953575 | Storz MVS-3201 Vitrectomy Probe Pack | Storz Instrument Co. | 1995 | — |
| 0 (this device) | K954816 | Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic Posterior… | Storz Instrument Co. | 1996 | — |
| +1 | K980488 | Storz Millennium Microsurgicl System High Speed Vitrectomy System | Storz Instrument Co. | 1998 | 4 |
| +2 | K031404 | Dignity Ophthalmic Surgical System | Phacor Inc., A Santen Company | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 HQE? 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 HQE device
- #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K953575 | Storz MVS-3201 Vitrectomy Probe PackSummary page 1…vitrectomy. Predicate Device: The STORZ DP4801, DP4800, and DP4801VP are substantially equivalent to the STORZ MVS-3201, DP4400 and DP4400VP anterior vitrectomy packs (K953575). Predicate Comparison: A chart comparing the STORZ DP4801, DP4800, and DP4801VP posterior vitrectomy packs to the predicate dev… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980488 | Storz Millennium Microsurgicl System High Speed Vitrectomy System | 1998 | 1 |
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 HQE devicesHQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQE
Too few HQE 510(k)s in any year since 2007 to give a median.
Recalls per year · HQE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQE
339in 2025
MAUDE reports naming product code HQE, 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 | — | 2 | 300 |
| 2008 | 0 | — | 0 | 65 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 11 | 27 |
| 2011 | 1 | — | 0 | 21 |
| 2012 | 2 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 4 | 10 |
| 2017 | 1 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 309 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 105 |
| 2025 | 0 | — | 1 | 339 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The STORZ DP4801, DP4800, and DP4801VP surgical accessory packs contain a vitrectomy probe and attached tubing set to be used in conjunction with the STORZ PREMIERE® or DAISY® Microsurgical Systems in the performance of posterior vitrectomy.
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/K954816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954816: Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic Posterior Vitrectomy Pack with Variable Port Cutter & RX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954816
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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