510(k) · Cleared
ClearedEndoview Spphire Lens Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Devices, Inc. · HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Cleared on Aug 6, 1997 as substantially equivalent to K902496 (Ocular Instruments, Inc., 1990) after a 78-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Aug 6, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- HJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902496 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902496 Landers Vitrectomy Lens Ring W/InfusionOcular Instruments, Inc. · 1990
- This deviceK971853 Endoview Spphire Lens SetAmerican Medical Devices, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902496 | Landers Vitrectomy Lens Ring W/Infusion | Ocular Instruments, Inc. | 1990 | — |
| 0 (this device) | K971853 | Endoview Spphire Lens Set | American Medical Devices, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K902496 | Landers Vitrectomy Lens Ring W/InfusionSummary page 2…t, which eliminates the need for the surgeon to constantly place irrigant on the corneal. This type of ring device is currently available from Ocular Instruments (510(k) 902496. Once the ring is in place, the surgeon places one of the lenses in the ring in order to visualize the posterior segment of the e… | 1990 |
| * | — | DORC lens set Named without a submission number | |
| * | — | Grieshaber lens set Named without a submission number | |
| † | K853129 | Beaver Multipurpose Sapphire Knife | 1985 |
| † | K860852 | Sapphire Blade Surgical Knife | 1986 |
| † | K861744 | Sapphire Knife Blade | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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?
For magnification during vitreoretinal surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971853: Endoview Spphire Lens Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971853
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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