510(k) · Cleared

Cleared

Univit Probe

K950287510(k) TraditionalCleared Apr 10, 199576-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. · HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered

Cleared on Apr 10, 1995 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Apr 10, 1995
Review: 76 days
Class: Class II
Product code: HKP
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK950287 Univit ProbeMedical Instrument Development Laboratories, Inc. · 1995
Descendant · cites it directly · 0 of its ownK081681 Vitrectomy Cutter and AccessoriesAdvanced Medical Optics, Inc. · 2008 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K081681Vitrectomy Cutter and AccessoriesAdvanced Medical Optics, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K950287	Univit Probe	Medical Instrument Development Laboratories, Inc.	1995	—
+1	K081681	Vitrectomy Cutter and Accessories	Advanced Medical Optics, Inc.	2008	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K950287, 1995–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HKP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K081681	Vitrectomy Cutter and Accessories	Advanced Medical Optics, Inc.	2008	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?

Of its descendants, K081681 (Advanced Medical Optics, Inc., 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HKP devices

HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HKP

FDA has decided no HKP device since 2007.

Median 510(k) review, days · HKP

Too few HKP 510(k)s in any year since 2007 to give a median.

Recalls per year · HKP

No recall names HKP since 2007.

Adverse event reports per year · HKP

1in 2022

2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code HKP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K950287 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950287: Univit Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950287

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026