510(k) · Cleared
ClearedBi-Blade Vitrectomy Cutter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Instrument Development Laboratories · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Apr 29, 2016 as substantially equivalent to K102222 (Medical Instrument Development Laboratories, Inc., 2011) after a 179-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Apr 29, 2016
- Review
- 179 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932669 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK932669 Supra-Vit (TM)Medical Instrument Development Laboratories, Inc. · 1994
- 3 generations backK992943 Vit EnhancerMedical Instrument Development Laboratories, Inc. · 1999
- 2 generations backK020911 Mid Labs Autonomous Vit Enhancer (Ave)Medical Instrument Development Laboratories, Inc. · 2002
- 1 generation backK102222 Ultimate Vit Enhamcer (Uve)Medical Instrument Development Laboratories, Inc. · 2011
- This deviceK153168 Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories · 2016
- Descendant · cites it directly · 0 of its ownK252052 Stellaris Elite™ vision enhancement system (BL11145, BL14455…Bausch and Lomb, Incorporated · 2026
Most influential descendants
Showing 1 of 1 · See all- K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565…Bausch and Lomb, Incorporated · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932669 | Supra-Vit (TM) | Medical Instrument Development Laboratories, Inc. | 1994 | — |
| −3 | K992943 | Vit Enhancer | Medical Instrument Development Laboratories, Inc. | 1999 | — |
| −2 | 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 | — |
| 0 (this device) | K153168 | Bi-Blade Vitrectomy Cutter | Medical Instrument Development Laboratories | 2016 | — |
| +1 | K252052 | Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455… | Bausch and Lomb, Incorporated | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K102222 | Ultimate Vit Enhamcer (Uve)Summary page 4…ame: Vitreous Aspiration & Cutting Instrument (86 HQE, 21 CFR 886.4150) III. Predicate Devices K102222 – Ultimate Vit Enhancer (UVE) and Accessories Premarket Notification 510(k) Submission Section… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252052 | Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565… | 2026 | 0 |
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 22 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K252052 (Bausch and Lomb, Incorporated, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102222.
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. 2016, this device’s year, is highlighted.
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 UVE and MID Labs Bi-Blade Vitrectomy 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 Bi-Blade Vitrectomy 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.
https://510kreport.com/device/K153168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153168: Bi-Blade Vitrectomy Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153168
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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