510(k) · Cleared
ClearedVolk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volk Optical, Inc. · HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Cleared on Aug 18, 2015 as substantially equivalent to K943125 (Volk Optical, Inc., 1994) and 2 other predicates after a 33-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Aug 18, 2015
- Review
- 33 days
- Class
- Class II
- Product code
- HJK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K943125 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK943125 Quadraspheric Fundus LensVolk Optical, Inc. · 1994
- 1 generation backK050623 Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx…Volk Optical, Inc. · 2005 · Recalled
- This deviceK151961 Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 2015
- 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 |
|---|---|---|---|---|---|
| −2 | K943125 | Quadraspheric Fundus Lens | Volk Optical, Inc. | 1994 | — |
| −1 | K050623 | Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D… | Volk Optical, Inc. | 2005 | 1 |
| 0 (this device) | K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | Volk Optical, Inc. | 2015 | — |
| +1 | K173944 | Endocular Viewing Lenses and Silicone Ring | Phakos | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
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 HJK? 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 HJK device
- #1 K201909 RxSight Contact Lensscore -0.0 · 1 generation · 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 |
|---|---|---|---|
| * | K943125 | Quadraspheric Fundus LensSummary page 4…me and Regulation Lens, Contact, Polymethylmethacrylate, Diagnostic 21 CFR 886.1385, HJK Ophthalmic Review Panel Predicate Device Quadraspheric Diagnostic Fundus Lens (K943125, Cleared on September 2, 1994) 7893 Enterprise Drive, Mentor, OH 44060 U.S.A. Phone: 800-345-8655 / 440-942-6161 Fax: 440… | 1994 |
| * | K023221 | Contact Laser & Diagnostic LensesSummary page 5…nt in design, material, classification, and intended use to the Volk Quadraspheric Fundus Lens (K943125) cleared on 9/2/1994, the Volk Contact Laser & Diagnostic Lenses (K023221) cleared on 10/11/2002, and the Volk Disposable Vitrectomy Lens (K050623) cleared on 5/28/2005, as seen in the chart below. Comp… | 2002 |
| * | K050623 | Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…Summary page 5…raspheric Fundus Lens (K943125) cleared on 9/2/1994, the Volk Contact Laser & Diagnostic Lenses (K023221) cleared on 10/11/2002, and the Volk Disposable Vitrectomy Lens (K050623) cleared on 5/28/2005, as seen in the chart below. Comparison Volk Disposable Volk Contac… | 2005 |
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?
- The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 10.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K173944 (Phakos, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K943125.
How does its category compare?
All HJK devicesHJK Lens, Contact, Polymethylmethacrylate, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HJK
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HJK
Too few HJK 510(k)s in any year since 2007 to give a median.
Recalls per year · HJK
No recall names HJK since 2007.
Adverse event reports per year · HJK
1in 2025
MAUDE reports naming product code HJK, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151961: Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151961
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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