510(k) · Cleared
ClearedProcare Plus Vitrectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visioncare Devices, Inc. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on May 30, 2012 as substantially equivalent to K980480 (Syntec, Inc., 1998) and 2 other predicates after a 132-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- May 30, 2012
- Review
- 132 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K896622 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K212763UniVit HE, UniVit UHSVisioncare Devices, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896622 | Visitec Vitrectomy Unit | Visitec Co. | 1990 | — |
| 0 (this device) | K120170 | Procare Plus Vitrectomy System | Visioncare Devices, Inc. | 2012 | — |
| +1 | K212763 | UniVit HE, UniVit UHS | Visioncare Devices, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K980480 | Syntec VitmanSummary page 1…886.4150 Vitreous Aspiration and cutting instrument. 5.7 Classification Name: Product Codes (HOE) K980480 - Syntec Vitman - HOC (Primary Predicate Device) 5.8 Predicate Devices K(904909 - YPR 2001 - HOE (Secondary Predica… | 1998 |
| * | K904909 | I/a Vitrophage Model Ypr 2001Summary page 6…for use, classification, and safety testing the ProCare Plus Vitrectomy System is substantially equivalent, in whole or part, to the listed predicate devices (K(980480, K904909, and K(896622). VisionCare Devices, Inc. FDA Device Registration Number 2939964 +1-530-243-5047, Kurtis~aVitcutter.com, Susan… | 1991 |
| * | K896622 | Visitec Vitrectomy UnitSummary page 3…Vitman YIPR 2001 Intrector 510(K) Number K(980480 K(904909 K896622 Anterior/Posterior Anterior/Posterior Anterior/Posterior Anterior/Posterior Intended… | 1990 |
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 |
|---|---|---|---|
| K212763 | UniVit HE, UniVit UHS | 2022 | 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K212763 (Visioncare Devices, LLC, 2022) has gone furthest, with 0 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. 2012, 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 VOID HSP VitCutter and Accessories is a single use (disposable) product intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module. The PROCARE PLUS TM Vitrectomy System is indicated for use in support of the following ophthalmic surgical procedures: Removal of vitreous in cases of…
Read the full statement (150 words)
The VOID HSP VitCutter and Accessories is a single use (disposable) product intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module.
The PROCARE PLUS TM Vitrectomy System is indicated for use in support of the following ophthalmic surgical procedures:
Removal of vitreous in cases of vitreous clouding, diabetic vitreal hemorrhaging, trauma, including contusions, penetrations, and intraocular foreign bodies; opacity, inflammation, endophthalmitis (bacterial or fungal), uvitis
* Removal of lens fragments after cataract surgery;
* Remove vitreous traction under the retina producing localized or complete retinal detachment
* Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis;
* Treatment of vitreous loss during cataract surgery;
* Clean vitreous strands from the cataract wound;
* Provide internal illumination for vitreous surgery;
* Provide air pressure for maintaining intraocular pressure for retinal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120170 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120170: Procare Plus Vitrectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120170
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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