510(k) · Cleared

Cleared

Syntec Vitman

K980480510(k) TraditionalCleared May 4, 199890-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

Syntec, Inc. · HQC Unit, Phacofragmentation

Cleared on May 4, 1998 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: May 4, 1998
Review: 90 days
Class: Class II
Product code: HQC
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK980480 Syntec VitmanSyntec, Inc. · 1998
Descendant · cites it directly · 1 of its ownK120170 Procare Plus Vitrectomy SystemVisioncare Devices, Inc. · 2012
Descendant · 2 generations on · 0 of its ownK212763 UniVit HE, UniVit UHSVisioncare Devices, LLC · 2022

Most influential descendants

Showing 2 of 2 · See all

K120170Procare Plus Vitrectomy SystemVisioncare Devices, Inc. · 2012 · cites it directly1descendant
K212763UniVit HE, UniVit UHSVisioncare Devices, LLC · 2022 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K980480	Syntec Vitman	Syntec, Inc.	1998	—
+1	K120170	Procare Plus Vitrectomy System	Visioncare Devices, Inc.	2012	—
+2	K212763	UniVit HE, UniVit UHS	Visioncare Devices, LLC	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2022	1	0

FIG. 1 — Lineage of K980480, 1998–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K120170	Procare Plus Vitrectomy System	Visioncare Devices, Inc.	2012	1

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, K120170 (Visioncare Devices, Inc., 2012) has gone furthest, with 1 descendant of its own.

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 Syntec VitMan is indicated for use in support of the following ophthalmic surgical procedures: Removal of vitreous in cases of: Vitreous cloudiness Diabetic vitreal hemorrhaging Trauma, including contusions, penetrations, and intraocular foreign bodies, Opecity Inflammation Endophthalmitis Bacterial Fungal Uveitis Removal of lens remnants after cataract surgery; Remove vitreous traction under the retina producing localized or complete retinal…

Read the full statement (111 words)

The Syntec VitMan is indicated for use in support of the following ophthalmic surgical procedures:

Removal of vitreous in cases of:

Vitreous cloudiness

Diabetic vitreal hemorrhaging

Trauma, including contusions, penetrations, and intraocular foreign bodies,

Opecity

Inflammation

Endophthalmitis

Bacterial

Fungal

Uveitis

Removal of lens remnants after cataract surgery;

Remove vitreous traction under the retina producing localized or complete retinal detachment;

Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis;

Treatment of vitreous loss during cataract surgery;

Clean vitreous strands from the cataract wound;

Perforﬁ emuisification of cataractous lens and its removal by aspiration and irrigation;

Provide internal illumination for vitreous surgery,

Provide air pressure for maintaining intraocular pressure for retinal surgery.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980480 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980480: Syntec Vitman.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980480

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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