510(k) · Cleared
ClearedStorz Microflow and Storz Standard Phacoemulsification Needles
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 Jun 17, 1997 as substantially equivalent to K954340 (Storz, 1995) and 3 other predicates after a 60-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jun 17, 1997
- Review
- 60 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K943102 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK943102 High Performance TipsSurgin Surgical Instrumentation, Inc. · 1994
- This deviceK971439 Storz Microflow and Storz Standard Phacoemulsification NeedlesStorz Instrument Co. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943102 | High Performance Tips | Surgin Surgical Instrumentation, Inc. | 1994 | — |
| 0 (this device) | K971439 | Storz Microflow and Storz Standard Phacoemulsification Needles | Storz Instrument Co. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K954340 | Storz Microflow Phacoemulsification NeedleSummary page 2…ed predicate devices. The Storz MicroFlow Plus and Storz MicroFlow Plus Angied Phaco Needles are subsatantially equivalent to the existing Storz MicroFlow Phaco Needles (K954340), the Storz MicroSeal Phaco Needles (K952259), and the Surgin High-Performance Phaco Tips (K943102). The Storz Standard Angled Ph… | 1995 |
| * | K952259 | Storz Microseal DP8030 & DP8045 Phacoemulsification NeedlesSummary page 2…s and Storz MicroFlow Plus Angied Phaco Needles are subsatantially equivalent to the existing Storz MicroFlow Phaco Needles (K954340), the Storz MicroSeal Phaco Needles (K952259), and the Surgin High-Performance Phaco Tips (K943102). The Storz Standard Angled Phaco Needles are substnatially equivalent to t… | 1995 |
| * | K943102 | High Performance TipsSummary page 2…bsatantially equivalent to the existing Storz MicroFlow Phaco Needles (K954340), the Storz MicroSeal Phaco Needles (K952259), and the Surgin High-Performance Phaco Tips (K943102). The Storz Standard Angled Phaco Needles are substnatially equivalent to the existing Storz Standard Phaco Needles (K946176) and… | 1994 |
| * | K946176 | Storz Phacoemulsification NeedlesSummary page 2…and the Surgin High-Performance Phaco Tips (K943102). The Storz Standard Angled Phaco Needles are substnatially equivalent to the existing Storz Standard Phaco Needles (K946176) and the Surgin High-Performance Phaco Tips (K943102). Charts comparing basic characteristics of these new Storz Phaco Needles to… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 3 of the 4 ancestors have a recall of any class.
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 MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are accessories to a phacoemulsification handpiece, intended for use in the ultrasonic surgical removal of the cataractous crystalline lens.
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/K971439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971439: Storz Microflow and Storz Standard Phacoemulsification Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971439
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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