510(k) · Cleared
ClearedSterile/Single Use Eye Sphere Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Instrument Co. · HPZ Implant, Eye Sphere
Cleared on Mar 30, 1992 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 30, 1992
- Review
- 21 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK921106 Sterile/Single Use Eye Sphere ImplantsStorz Instrument Co. · 1992
- Descendant · cites it directly · 3 of its ownK972661 Eye Sphere, ConformersGulden Ophthalmics · 1997 · Recalled
- Descendant · 2 generations on · 1 of its ownK070130 Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK083342 Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK082850 Eye SpheresProduct and Educational Services, LLC · 2009
Most influential descendants
Showing 4 of 4 · See all- K972661Eye Sphere, ConformersGulden Ophthalmics · 1997 · cites it directly3descendants
- K070130Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007 · 2 generations on1descendant
- K083342Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009 · 3 generations on0descendants
- K082850Eye SpheresProduct and Educational Services, LLC · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921106 | Sterile/Single Use Eye Sphere Implants | Storz Instrument Co. | 1992 | — |
| +1 | K972661 | Eye Sphere, Conformers | Gulden Ophthalmics | 1997 | 13 |
| +2 | K070130 | Orbital Reconstructive Implant | Becker & Associates Consulting, Inc. | 2007 | — |
| +3 | K083342 | Orbital Reconstructive Implant II | Evera Medical, Inc. | 2009 | — |
| +2 | K082850 | Eye Spheres | Product and Educational Services, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 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 HPZ? 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 HPZ device
- #1 K212741 Ezyporscore 3.6 · 1 generation · no Class I recall
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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972661 | Eye Sphere, Conformers | 1997 | 3 |
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, K972661 (Gulden Ophthalmics, 1997) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HPZ devicesHPZ Implant, Eye Sphere: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HPZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HPZ
Too few HPZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HPZ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HPZ
6in 2011
MAUDE reports naming product code HPZ, 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 | 2 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 2 | — | 0 | 6 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 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 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K921106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921106: Sterile/Single Use Eye Sphere Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921106
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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