510(k) · Cleared
ClearedQuadraspheric Fundus 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 Sep 2, 1994 after a 65-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 2, 1994
- Review
- 65 days
- Class
- Class II
- Product code
- HJK
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK943125 Quadraspheric Fundus LensVolk Optical, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK050623 Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx…Volk Optical, Inc. · 2005 · Recalled
- Descendant · cites it directly · 1 of its ownK151961 Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK051103 Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK173944 Endocular Viewing Lenses and Silicone RingPhakos · 2018
- Descendant · 2 generations on · 0 of its ownK052674 Contact Lens OphthalmodynamometerMeditron, GmbH · 2006
Most influential descendants
Showing 5 of 5 · See all- K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…Volk Optical, Inc. · 2005 · cites it directly2descendants
- K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 2015 · cites it directly1descendant
- K051103Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc. · 2005 · cites it directly1descendant
- K173944Endocular Viewing Lenses and Silicone RingPhakos · 2018 · 2 generations on0descendants
- K052674Contact Lens OphthalmodynamometerMeditron, GmbH · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +1 | K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | Volk Optical, Inc. | 2015 | — |
| +1 | K051103 | Haag-Streit Contact Glasses Stery Cup, Accessory | Haag-Streit USA, Inc. | 2005 | — |
| +2 | K173944 | Endocular Viewing Lenses and Silicone Ring | Phakos | 2018 | — |
| +2 | K052674 | Contact Lens Ophthalmodynamometer | Meditron, GmbH | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050623 (Volk Optical, Inc., 2005) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K943125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943125: Quadraspheric Fundus Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943125
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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