510(k) · Cleared
ClearedMid Labs Autonomous Vit Enhancer (Ave)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Instrument Development Laboratories, Inc. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Apr 29, 2002 as substantially equivalent to K992943 (Medical Instrument Development Laboratories, Inc., 1999) and 1 other predicate after a 40-day review. Its family tree reaches back 2 generations to 1994. 9 later devices descend from it.
- Decided
- Apr 29, 2002
- Review
- 40 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932669 (1994). 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK932669 Supra-Vit (TM)Medical Instrument Development Laboratories, Inc. · 1994
- 1 generation backK992943 Vit EnhancerMedical Instrument Development Laboratories, Inc. · 1999
- This deviceK020911 Mid Labs Autonomous Vit Enhancer (Ave)Medical Instrument Development Laboratories, Inc. · 2002
- Descendant · cites it directly · 8 of its ownK102222 Ultimate Vit Enhamcer (Uve)Medical Instrument Development Laboratories, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- Descendant · 3 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 · 3 generations on · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK212241 Quatera 700Carl Zeiss Meditec, AG · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K102222Ultimate Vit Enhamcer (Uve)Medical Instrument Development Laboratories, Inc. · 2011 · cites it directly8descendants
- K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · 2 generations on5descendants
- K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · 3 generations on2descendants
- K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · 3 generations on1descendant
- K212241Quatera 700Carl Zeiss Meditec, AG · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932669 | Supra-Vit (TM) | Medical Instrument Development Laboratories, Inc. | 1994 | — |
| −1 | K992943 | Vit Enhancer | Medical Instrument Development Laboratories, Inc. | 1999 | — |
| 0 (this device) | K020911 | Mid Labs Autonomous Vit Enhancer (Ave) | Medical Instrument Development Laboratories, Inc. | 2002 | — |
| +1 | K102222 | Ultimate Vit Enhamcer (Uve) | Medical Instrument Development Laboratories, Inc. | 2011 | — |
| +2 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| +3 | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser… | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019 | 1 |
| +3 | K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022 | 6 |
| +3 | K212241 | Quatera 700 | Carl Zeiss Meditec, AG | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K992943 | Vit EnhancerSummary page 1…™, MID Labs SupraVit® Vitreoretinal Surgical System Predicate Device Comparison Table Device Autonomous Vit Vit Enhancer SupraVit Description Enhancer 510(k) current K992943 K932669 Number Intended Use vitreous cutting vitreous cutting Posterior segment ophthalmic surgery, including vitreous cutting… | 1999 |
| * | K932669 | Supra-Vit (TM)Summary page 1…abs SupraVit® Vitreoretinal Surgical System Predicate Device Comparison Table Device Autonomous Vit Vit Enhancer SupraVit Description Enhancer 510(k) current K992943 K932669 Number Intended Use vitreous cutting vitreous cutting Posterior segment ophthalmic surgery, including vitreous cutting Vitreou… | 1994 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102222 | Ultimate Vit Enhamcer (Uve) | 2011 | 8 |
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 8 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102222 (Medical Instrument Development Laboratories, Inc., 2011) has gone furthest, with 8 descendants of its own.
How does its category compare?
All HQE devicesHQE 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
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQE
339in 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 AVE is used in conjuction with ophthalmic surgical equipment (typically phacoemulsification or vitreoretinal surgical equipment) to remove vitreous and 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/K020911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020911: Mid Labs Autonomous Vit Enhancer (Ave).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020911
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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