510(k) · Cleared

Cleared

Storz DP5100 Anterior Collection Cassette Pack

K961874510(k) TraditionalCleared Aug 6, 199683-day reviewClass II21 CFR 886.4670

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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 83-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.

Decided: Aug 6, 1996
Review: 83 days
Class: Class II
Product code: HQC
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K894278 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK894278 Storz Daisyplus Series Microsurgical SystemsStorz Instrument Co. · 1989
This deviceK961874 Storz DP5100 Anterior Collection Cassette 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
−1	K894278	Storz Daisyplus Series Microsurgical Systems	Storz Instrument Co.	1989	—
0 (this device)	K961874	Storz DP5100 Anterior Collection Cassette 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
1992	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K961874, 1989–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K894278	Storz Daisyplus Series Microsurgical Systems Summary page 1 …gle collection cassette. This component is intended to be used as an accessory to the Storz DAISY ® (K854508), Storz Protegé ® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segme…	Storz Instrument Co.	1989	—
*	K921758	Storz Protege Opthalmic Microsurgical System Summary page 1 …100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY ® (K854508), Storz Protegé ® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid…	Storz Instrument Co.	1992	—
*	K953078	Storz DP4101 Basic I/a Pack Summary page 1 …nt to the existing Storz DP5100 Ambulatory Surgery Center (ASC) Collection Cassette Pack (K894278, K921758), and to the Storz DP4101 Basic Irrigation / Aspiration Pack (K953078). Predicate Comparison: A chart comparing the Storz DP5100, as modified, to the predicate devices, demonstrating substantial equ…	Storz Instrument Co.	1995	—

Also cleared against K894278: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K990292	I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack…	Ophthalmic Consultants, Inc.	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?

None of the 3 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 devices

HQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQC

3in 2025

2007high 5 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQC

267in 2025

2007high 267 (2025) · low 124 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HQC

1in 2025

2007high 22 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQC

1,799in 2025

2007high 3,374 (2016) · low 341 (2007)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 DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY ® (K854508), Storz Protegé ® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during 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/K961874 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961874: Storz DP5100 Anterior Collection Cassette Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961874

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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