510(k) · Cleared

Cleared

Vit Enhancer

K992943510(k) TraditionalCleared Dec 10, 1999101-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

Medical Instrument Development Laboratories, Inc. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Cleared on Dec 10, 1999 as substantially equivalent to K932669 (Medical Instrument Development Laboratories, Inc., 1994) after a 101-day review. Its family tree reaches back 1 generation to 1994. 10 later devices descend from it.

Decided: Dec 10, 1999
Review: 101 days
Class: Class II
Product code: HQE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K932669 (1994). 10 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK932669 Supra-Vit (TM)Medical Instrument Development Laboratories, Inc. · 1994
This deviceK992943 Vit EnhancerMedical Instrument Development Laboratories, Inc. · 1999
Descendant · cites it directly · 9 of its ownK020911 Mid Labs Autonomous Vit Enhancer (Ave)Medical Instrument Development Laboratories, Inc. · 2002
Descendant · 2 generations on · 8 of its ownK102222 Ultimate Vit Enhamcer (Uve)Medical Instrument Development Laboratories, Inc. · 2011
Descendant · 3 generations on · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
Descendant · 4 generations on · 2 of its ownK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
Descendant · 4 generations on · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2002high 2 (2022) · low 0 (2003)2026

Most influential descendants

Showing 5 of 10 · See all

K020911Mid Labs Autonomous Vit Enhancer (Ave)Medical Instrument Development Laboratories, Inc. · 2002 · cites it directly9descendants
K102222Ultimate Vit Enhamcer (Uve)Medical Instrument Development Laboratories, Inc. · 2011 · 2 generations on8descendants
K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · 3 generations on5descendants
K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · 4 generations on2descendants
K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932669	Supra-Vit (TM)	Medical Instrument Development Laboratories, Inc.	1994	—
0 (this device)	K992943	Vit Enhancer	Medical Instrument Development Laboratories, Inc.	1999	—
+1	K020911	Mid Labs Autonomous Vit Enhancer (Ave)	Medical Instrument Development Laboratories, Inc.	2002	—
+2	K102222	Ultimate Vit Enhamcer (Uve)	Medical Instrument Development Laboratories, Inc.	2011	—
+3	K142877	EVA,anterior machine, EVA, combined machine, EVA combined machine with laser…	Dutch Ophthalmic Research Center International BV	2015	—
+4	K190875	EVA, anterior machine, EVA, combined machine, EVA combined machine with laser…	D.O.R.C. Dutch Ophthalmic Research Center (International)	2019	1
+4	K213467	EVA NEXUS Ophthalmic Surgical System	D.O.R.C. Dutch Ophthalmic Research Center (International)	2022	6

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2011	1	0
2015	1	0
2016	1	0
2019	1	0
2022	2	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K992943, 1994–2026Source: 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 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 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall

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What was it cleared against? (1)

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
*	K932669	Supra-Vit (TM) Summary page 1 …r. Predicate Device: MID Labs SupraVit® Vitreoretinal Surgical System Predicate Device Comparison Table Device Vit Enhancer SupraVit Description 510(k) Number current K932669 Intended Use vitreous cutting posterior segment ophthalmic surgery, including vitreous cutting Vitreous Cutter Type guilloti…	Medical Instrument Development Laboratories, Inc.	1994	—

Also cleared against K932669: 2 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K020911	Mid Labs Autonomous Vit Enhancer (Ave)	Medical Instrument Development Laboratories, Inc.	2002	9

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?

Its one ancestor has no recall.
Of its descendants, K020911 (Medical Instrument Development Laboratories, Inc., 2002) has gone furthest, with 9 descendants of its own.
2 other devices also cite its predicate K932669.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	2	300
2008	0	—	0	65
2009	0	—	0	34
2010	0	—	11	27
2011	1	—	0	21
2012	2	—	0	34
2013	0	—	0	9
2014	1	—	0	9
2015	0	—	0	9
2016	1	—	4	10
2017	1	—	0	59
2018	0	—	0	309
2019	0	—	0	41
2020	0	—	0	30
2021	0	—	0	32
2022	1	—	0	46
2023	0	—	0	108
2024	0	—	0	105
2025	0	—	1	339
2026	0	—	3	—

What is it indicated for?

The Vit Enhancer in conjunction with standard vitrectomy equipment is used

to remove vitreous and other intraocular tissue.

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/K992943 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992943: Vit Enhancer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992943

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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