510(k) · Cleared

Cleared

Visitec Vitrectomy Unit

K896622510(k) TraditionalCleared Apr 4, 1990134-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

Visitec Co. · HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered

Cleared on Apr 4, 1990 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Apr 4, 1990
Review: 134 days
Class: Class II
Product code: HKP
Recalls: None
Predicates: 0

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

This deviceK896622 Visitec Vitrectomy UnitVisitec Co. · 1990
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)	K896622	Visitec Vitrectomy Unit	Visitec Co.	1990	—
+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 K896622, 1990–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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? (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 HKP devices

HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HKP

FDA has decided no HKP device since 2007.

Median 510(k) review, days · HKP

Too few HKP 510(k)s in any year since 2007 to give a median.

Recalls per year · HKP

No recall names HKP since 2007.

Adverse event reports per year · HKP

1in 2022

2007high 1 (2022) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K896622 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896622: Visitec Vitrectomy Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896622

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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