510(k) Report

510(k) · Cleared

Cleared

Storz Premiere/Premiere Microvit Microsurg Systems

K921460510(k) TraditionalCleared Jul 2, 199297-day reviewClass II21 CFR 886.4150

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

Storz Instrument Co. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Cleared on Jul 2, 1992 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.

Decided
Jul 2, 1992
Review
97 days
Class
Class II
Product code
HQE
Recalls
None
Predicates
0

57 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared1998: 1 descendant cleared2001: 1 descendant cleared2003: 1 descendant cleared2010: 2 descendants cleared2017: 7 descendants cleared2005: 1 descendant cleared2014: 4 descendants cleared2011: 3 descendants cleared2008: 1 descendant cleared2012: 8 descendants cleared2013: 2 descendants cleared2016: 2 descendants cleared2015: 6 descendants cleared2021: 2 descendants cleared2018: 6 descendants cleared2023: 2 descendants cleared2022: 3 descendants cleared2020: 2 descendants cleared2025: 2 descendants cleared1990200020102020
  1. This deviceK921460 Storz Premiere/Premiere Microvit Microsurg SystemsStorz Instrument Co. · 1992
  2. Descendant · cites it directly · 49 of its ownK993154 Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp. · 2000 · Recalled
  3. Descendant · 2 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
  4. Descendant · 3 generations on · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
  5. Descendant · 4 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
  6. Descendant · 3 generations on · 13 of its ownK113479 Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · Recalled

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

1998: 12000: 12001: 12003: 12005: 12008: 12010: 22011: 32012: 82013: 22014: 42015: 62016: 22017: 72018: 62020: 22021: 22022: 32023: 22025: 2
1998high 8 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 57 · See all
  • K993154Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp. · 2000 · cites it directly49descendants
  • K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 2 generations on47descendants
  • K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · 3 generations on30descendants
  • K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 4 generations on19descendants
  • K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · 3 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921460Storz Premiere/Premiere Microvit Microsurg SystemsStorz Instrument Co.1992—
+1K993154Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp.20001
+2K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc.2010—
+3K101626Lensx Laser SystemLensx Lasers, Inc.2010—
+4K113151Ifs Laser SystemAbbott Medical Optics, Inc.2012—
+3K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation20112

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200110
200310
200510
200810
201020
201130
201280
201320
201440
201560
201620
201770
201860
202020
202120
202230
202320
202520
FIG. 1 — Lineage of K921460, 1992–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
Get a 510(k) 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? (57)

See all 57

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993154Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp.200049
K981103Turbosonics Limited Reuse Ultrasonic TipAlcon Laboratories19986

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, K993154 (A.R.C. Laser Corp., 2000) has gone furthest, with 49 descendants of its own.

How does its category compare?

All HQE devices

HQE 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

2011: 12012: 22014: 12016: 12017: 12022: 1
2007high 2 (2012) · low 0 (2007)2026

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

2007: 22010: 112016: 42025: 12026 (partial year): 3
2007high 11 (2010) · low 0 (2008)2026

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

Adverse event reports per year · HQE

339in 2025

2007: 3002008: 652009: 342010: 272011: 212012: 342013: 92014: 92015: 92016: 102017: 592018: 3092019: 412020: 302021: 322022: 462023: 1082024: 1052025: 339
2007high 339 (2025) · low 9 (2013)2025

MAUDE reports naming product code HQE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—2300
20080—065
20090—034
20100—1127
20111—021
20122—034
20130—09
20141—09
20150—09
20161—410
20171—059
20180—0309
20190—041
20200—030
20210—032
20221—046
20230—0108
20240—0105
20250—1339
20260—3—

More from Storz Instrument Co.

101 FDA decisions under this applicant name. See the company

  • K980100Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc DaypackStorz Instrument Co. · 1998
  • K980488Storz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co. · 19984 recalls
  • K972664Storz Millennium Viscous Fluid SystemStorz Instrument Co. · 1997
  • K971439Storz Microflow and Storz Standard Phacoemulsification NeedlesStorz Instrument Co. · 1997
  • K964743Storz E8010 Ergotec/Premiere AdaptorStorz Instrument Co. · 1997

Recent decisions in HQE

The HQE category page

  • K212763UniVit HE, UniVit UHSVisioncare Devices, LLC · 2022
  • K170183Cetus system, Cetus probeA.R.C Laser GmbH · 2017
  • K153168Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories · 2016
  • K141065Constellation Vision SystemAlcon Research, Ltd. · 20146 recalls
  • K121675VersavitSynergetics, Inc. · 20124 recalls

https://510kreport.com/device/K921460 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921460: Storz Premiere/Premiere Microvit Microsurg Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921460

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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