510(k) Report

510(k) · Cleared

Cleared

Ultimate Vit Enhamcer (Uve)

K102222510(k) TraditionalCleared Apr 8, 2011245-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 Apr 8, 2011 as substantially equivalent to K020911 (Medical Instrument Development Laboratories, Inc., 2002) after a 245-day review. Its family tree reaches back 3 generations to 1994. 8 later devices descend from it.

Decided
Apr 8, 2011
Review
245 days
Class
Class II
Product code
HQE
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K932669 (1994). 8 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2016: 1 descendant cleared2019: 1 descendant cleared2022: 2 descendants cleared2026: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant clearedK932669 · Supra-Vit (TM) · Medical Instrument Development Laboratories, Inc. · 1994K992943 · Vit Enhancer · Medical Instrument Development Laboratories, Inc. · 1999K020911 · Mid Labs Autonomous Vit Enhancer (Ave) · Medical Instrument Development Laboratories, Inc. · 20021990200020102020
  1. Root · 3 generations backK932669 Supra-Vit (TM)Medical Instrument Development Laboratories, Inc. · 1994
  2. 2 generations backK992943 Vit EnhancerMedical Instrument Development Laboratories, Inc. · 1999
  3. 1 generation backK020911 Mid Labs Autonomous Vit Enhancer (Ave)Medical Instrument Development Laboratories, Inc. · 2002
  4. This deviceK102222 Ultimate Vit Enhamcer (Uve)Medical Instrument Development Laboratories, Inc. · 2011
  5. Descendant · cites it directly · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
  6. Descendant · 2 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
  7. Descendant · 2 generations on · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
  8. Descendant · 2 generations on · 1 of its ownK212241 Quatera 700Carl Zeiss Meditec, AG · 2022
  9. Descendant · cites it directly · 1 of its ownK153168 Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories · 2016

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12019: 12022: 22023: 12025: 12026: 1
2015high 2 (2022) · low 0 (2017)2026

Most influential descendants

Showing 5 of 8 · See all
  • K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · cites it directly5descendants
  • K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · 2 generations on2descendants
  • K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · 2 generations on1descendant
  • K212241Quatera 700Carl Zeiss Meditec, AG · 2022 · 2 generations on1descendant
  • K153168Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories · 2016 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K932669Supra-Vit (TM)Medical Instrument Development Laboratories, Inc.1994—
−2K992943Vit EnhancerMedical Instrument Development Laboratories, Inc.1999—
−1K020911Mid Labs Autonomous Vit Enhancer (Ave)Medical Instrument Development Laboratories, Inc.2002—
0 (this device)K102222Ultimate Vit Enhamcer (Uve)Medical Instrument Development Laboratories, Inc.2011—
+1K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser…Dutch Ophthalmic Research Center International BV2015—
+2K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser…D.O.R.C. Dutch Ophthalmic Research Center (International)20191
+2K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)20226
+2K212241Quatera 700Carl Zeiss Meditec, AG2022—
+1K153168Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201910
202220
202310
202510
202610
FIG. 1 — Lineage of K102222, 1994–2026Source: 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), 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. #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K020911Mid Labs Autonomous Vit Enhancer (Ave)
Summary page 1
…Comparison Table Device UVE AVE Description Ultimate Vit Enhancer 510(k) Current K020911 Number Intended Use Vitreous cutting Vitreous cutting Vitreous Guillotine…
Medical Instrument Development Laboratories, Inc.2002—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155
K153168Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories20161

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?

  • The line of descent spans 17 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K142877 (Dutch Ophthalmic Research Center International BV, 2015) has gone furthest, with 5 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. 2011, this device’s year, is highlighted.

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—

What is it indicated for?

The UVE and the MID Labs Vitreous Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Vitreous Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K102222: Ultimate Vit Enhamcer (Uve).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102222

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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