510(k) · Cleared
ClearedStorz DP4101 Basic I/a 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 7, 1995 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 7, 1995
- Review
- 35 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK953078 Storz DP4101 Basic I/a PackStorz Instrument Co. · 1995
- Descendant · cites it directly · 1 of its ownK961874 Storz DP5100 Anterior Collection Cassette PackStorz Instrument Co. · 1996
- Descendant · 2 generations on · 0 of its ownK990292 I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior…Ophthalmic Consultants, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK961820 Storz DP4600 Anterior Intraocular Pressure Control PackStorz Instrument Co. · 1996
Most influential descendants
Showing 3 of 3 · See all- K961874Storz DP5100 Anterior Collection Cassette PackStorz Instrument Co. · 1996 · cites it directly1descendant
- K990292I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack…Ophthalmic Consultants, Inc. · 1999 · 2 generations on0descendants
- K961820Storz DP4600 Anterior Intraocular Pressure Control PackStorz Instrument Co. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953078 | Storz DP4101 Basic I/a Pack | Storz Instrument Co. | 1995 | — |
| +1 | K961874 | Storz DP5100 Anterior Collection Cassette Pack | Storz Instrument Co. | 1996 | — |
| +2 | K990292 | I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy… | Ophthalmic Consultants, Inc. | 1999 | — |
| +1 | K961820 | Storz DP4600 Anterior Intraocular Pressure Control Pack | Storz Instrument Co. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 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?
- Of its descendants, K961874 (Storz Instrument Co., 1996) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K953078 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953078: Storz DP4101 Basic I/a Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953078
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026