510(k) · Cleared

Cleared

Turbosonics Limited Reuse Ultrasonic Tip

K981103510(k) TraditionalCleared Jun 23, 199889-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

Alcon Laboratories · HQC Unit, Phacofragmentation

Cleared on Jun 23, 1998 as substantially equivalent to K911808 (Alcon Laboratories, 1991) and 7 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1985. 6 later devices descend from it.

Decided: Jun 23, 1998
Review: 89 days
Class: Class II
Product code: HQC
Recalls: None
Predicates: 8

Its longest line of descent runs back 1 generation to K851210 (1985). 8 ancestors in all. 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK851210 United Sonics Phaco Module, DF-35United Sonics, Inc. · 1985
This deviceK981103 Turbosonics Limited Reuse Ultrasonic TipAlcon Laboratories · 1998
Descendant · cites it directly · 4 of its ownK030179 Medisiss Phacoemulsification Tips/NeedlesSurgical Instruments Service and Savings, Inc. · 2003 · Recalled
Descendant · 2 generations on · 3 of its ownK041841 PachycamOculus Optikgerate GmbH · 2005
Descendant · 3 generations on · 1 of its ownK073508 ParkoneOculus Optikgerate GmbH · 2008
Descendant · 4 generations on · 0 of its ownK202989 Myopia MasterOculus Optikgeräte GmbH · 2021 · Recalled
Descendant · 3 generations on · 0 of its ownK113066 Corvis STOculus Optikgerate GmbH · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2001high 1 (2001) · low 0 (2002)2026

Most influential descendants

Showing 5 of 6 · See all

K030179Medisiss Phacoemulsification Tips/NeedlesSurgical Instruments Service and Savings, Inc. · 2003 · cites it directly4descendants
K041841PachycamOculus Optikgerate GmbH · 2005 · 2 generations on3descendants
K073508ParkoneOculus Optikgerate GmbH · 2008 · 3 generations on1descendant
K202989Myopia MasterOculus Optikgeräte GmbH · 2021 · 4 generations on0descendants
K113066Corvis STOculus Optikgerate GmbH · 2012 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K851210	United Sonics Phaco Module, DF-35	United Sonics, Inc.	1985	—
0 (this device)	K981103	Turbosonics Limited Reuse Ultrasonic Tip	Alcon Laboratories	1998	—
+1	K030179	Medisiss Phacoemulsification Tips/Needles	Surgical Instruments Service and Savings, Inc.	2003	1
+2	K041841	Pachycam	Oculus Optikgerate GmbH	2005	—
+3	K073508	Parkone	Oculus Optikgerate GmbH	2008	—
+4	K202989	Myopia Master	Oculus Optikgeräte GmbH	2021	1
+3	K113066	Corvis ST	Oculus Optikgerate GmbH	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	1	0
1992	4	0
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2005	1	0
2008	1	0
2012	1	0
2021	1	0

FIG. 1 — Lineage of K981103, 1985–2021Source: 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? (8)

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
*	K911808	Gemini Ophthalmic Surgery System Summary page 2 …e Device K781/03 We are claiming equivalence of the Alcon Limited Reuse tip to the phacoemulsification ultrasonic tips used in the following legally marketed devices: K9 11808 ”A‘l.co.nFSeribes 20,006E Legacyt Alcon Surgical K851210 United Sonics Phaco Module Model PF-35 United Sonics, Inc. K902876 Pha…	Alcon Laboratories	1991	2
*	K851210	United Sonics Phaco Module, DF-35 Summary page 2 …Limited Reuse tip to the phacoemulsification ultrasonic tips used in the following legally marketed devices: K9 11808 ”A‘l.co.nFSeribes 20,006E Legacyt Alcon Surgical K851210 United Sonics Phaco Module Model PF-35 United Sonics, Inc. K902876 Phacotron Systems Plus III Phacoemulsifier Aspirator \| Intraop…	United Sonics, Inc.	1985	—
*	K902876	Phacotron Systems Plus Iii Phacoemulsifier Aspi. Summary page 2 …n the following legally marketed devices: K9 11808 ”A‘l.co.nFSeribes 20,006E Legacyt Alcon Surgical K851210 United Sonics Phaco Module Model PF-35 United Sonics, Inc. K902876 Phacotron Systems Plus III Phacoemulsifier Aspirator \| Intraoptics Surgical K915456 United Sonics Phaco 3000 Linear Innovative Me…	Intraoptics Surgical, Inc.	1990	—
*	K915456	Phaco 3000 Linear Summary page 2 …t Alcon Surgical K851210 United Sonics Phaco Module Model PF-35 United Sonics, Inc. K902876 Phacotron Systems Plus III Phacoemulsifier Aspirator \| Intraoptics Surgical K915456 United Sonics Phaco 3000 Linear Innovative Medical Systems K915457 United Sonics Phaco 20/20 System I “ K921460 Storz Premiere™/…	Innovative Medical Systems, Inc.	1992	—
*	K915457	Phaco 20/20 System I Summary page 2 …nited Sonics, Inc. K902876 Phacotron Systems Plus III Phacoemulsifier Aspirator \| Intraoptics Surgical K915456 United Sonics Phaco 3000 Linear Innovative Medical Systems K915457 United Sonics Phaco 20/20 System I “ K921460 Storz Premiere™/ Premiere™ Microvit® Storz Instrument Company K921758 Storz Protege…	Innovative Medical Systems, Inc.	1992	—
*	K921460	Storz Premiere/Premiere Microvit Microsurg Systems Summary page 2 …lus III Phacoemulsifier Aspirator \| Intraoptics Surgical K915456 United Sonics Phaco 3000 Linear Innovative Medical Systems K915457 United Sonics Phaco 20/20 System I “ K921460 Storz Premiere™/ Premiere™ Microvit® Storz Instrument Company K921758 Storz Protege™ Ophthalmic Microsurgical System “ K925631 P…	Storz Instrument Co.	1992	—
*	K921758	Storz Protege Opthalmic Microsurgical System Summary page 2 …d Sonics Phaco 3000 Linear Innovative Medical Systems K915457 United Sonics Phaco 20/20 System I “ K921460 Storz Premiere™/ Premiere™ Microvit® Storz Instrument Company K921758 Storz Protege™ Ophthalmic Microsurgical System “ K925631 Phacotron Gold™ Multifunction Ultrasonic Handpiece \| Chiron IntraOptics…	Storz Instrument Co.	1992	—
*	K925631	Phacotron Gold Multifunction Ultrasonic Handpiece Summary page 2 …457 United Sonics Phaco 20/20 System I “ K921460 Storz Premiere™/ Premiere™ Microvit® Storz Instrument Company K921758 Storz Protege™ Ophthalmic Microsurgical System “ K925631 Phacotron Gold™ Multifunction Ultrasonic Handpiece \| Chiron IntraOptics 2. Device Description The Series 20000® Legacy® System…	Chiron Intraoptics	1993	—

Also cleared against K911808: 13 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K030179	Medisiss Phacoemulsification Tips/Needles	Surgical Instruments Service and Savings, Inc.	2003	4
K012579	Reprocessed Phaco Tips	Sterilmed, Inc.	2001	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?

1 of the 8 ancestors has a recall of any class.
Of its descendants, K030179 (Surgical Instruments Service and Savings, Inc., 2003) has gone furthest, with 4 descendants of its own.
13 other devices also cite its predicate K911808.

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 intended use of this device is to assist in the automated phacoemulsification of a natural 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/K981103 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981103: Turbosonics Limited Reuse Ultrasonic Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981103

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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