510(k) · Cleared
ClearedFamily of Disposable Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensor Medical Technology, LLC · HKS Prism, Gonioscopic
Cleared on Apr 29, 2014 after a 74-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Apr 29, 2014
- Review
- 74 days
- Class
- Class I
- Product code
- HKS
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK140368 Family of Disposable LensesSensor Medical Technology, LLC · 2014
- Descendant · cites it directly · 0 of its ownK173944 Endocular Viewing Lenses and Silicone RingPhakos · 2018
Most influential descendants
Showing 1 of 1 · See all- K173944Endocular Viewing Lenses and Silicone RingPhakos · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140368 | Family of Disposable Lenses | Sensor Medical Technology, LLC | 2014 | — |
| +1 | K173944 | Endocular Viewing Lenses and Silicone Ring | Phakos | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 HKS? 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
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K102371 | Sensor Family of Ophthalmic Lenses Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…1 CFR 886.1660, HKS Ophthalmic Panel Diagnostic Condensing Lens 21 CFR 886.1380, HJL Ophthalmic Panel Predicate Devices Sensor Family of Ophthalmic Lenses (K102371) Device Description The Sensor Medical Technology Family of Disposable Lenses is a family of diagnostic and therapeutic co… |
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 |
|---|---|---|---|
| K173944 | Endocular Viewing Lenses and Silicone Ring | 2018 | 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, K173944 (Phakos, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HKS devicesHKS Prism, Gonioscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HKS
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HKS
Too few HKS 510(k)s in any year since 2007 to give a median.
Recalls per year · HKS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKS
1in 2022
MAUDE reports naming product code HKS, 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 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sensor Medical Technology Family of Disposable Lenses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and irido-corneal and vitreous bodies and for the laser therapy of intraocular abnormalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140368: Family of Disposable Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140368
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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