510(k) · Cleared
Recalled · Class II · 2025Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D
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 Mar 28, 2005 as substantially equivalent to K012096 (Ocular Instruments, Inc., 2001) and 1 other predicate after an 18-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 28, 2005
- Review
- 18 days
- Class
- Class II
- Product code
- HJK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943125 (1994). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK943125 Quadraspheric Fundus LensVolk Optical, Inc. · 1994
- This deviceK050623 Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx…Volk Optical, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK151961 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943125 | Quadraspheric Fundus Lens | Volk Optical, Inc. | 1994 | — |
| 0 (this device) | K050623 | Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D… | Volk Optical, Inc. | 2005 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (2)
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.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2025 | Class II | Z-1244-2026 | Employee error | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HJK devicesHJK Lens, Contact, Polymethylmethacrylate, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapV of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050623 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050623: Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050623
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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