510(k) · Cleared
ClearedHaag-Streit Contact Glasses Stery Cup, Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haag-Streit USA, Inc. · HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Cleared on Jun 7, 2005 as substantially equivalent to K943125 (Volk Optical, Inc., 1994) and 2 other predicates after a 39-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jun 7, 2005
- Review
- 39 days
- Class
- Class II
- Product code
- HJK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K943125 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K052674Contact Lens OphthalmodynamometerMeditron, GmbH · 2006 · cites it directly0descendants
View 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) | K051103 | Haag-Streit Contact Glasses Stery Cup, Accessory | Haag-Streit USA, Inc. | 2005 | — |
| +1 | K052674 | Contact Lens Ophthalmodynamometer | Meditron, GmbH | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 2…s. The HS Contact Glasses are substantially equivalent to diagnostic and laser therapy use lenses marketed by Volk Opti(al Inc. (Quadraspheric Fundus Lens- K943125 and K023221) and Ocular Instruments Inc. (Saurenghi Scan Laser Lens- K014170). 23 May 2005 Vers: Correctionl === P… | 1994 |
| * | K023221 | Contact Laser & Diagnostic LensesSummary page 2…ntact Glasses are substantially equivalent to diagnostic and laser therapy use lenses marketed by Volk Opti(al Inc. (Quadraspheric Fundus Lens- K943125 and K023221) and Ocular Instruments Inc. (Saurenghi Scan Laser Lens- K014170). 23 May 2005 Vers: Correctionl ”,… | 2002 |
| * | K014170 | Staurenghi Wide Field Scanning Laser LensSummary page 2…therapy use lenses marketed by Volk Opti(al Inc. (Quadraspheric Fundus Lens- K943125 and K023221) and Ocular Instruments Inc. (Saurenghi Scan Laser Lens- K014170). 23 May 2005 Vers: Correctionl ”, sll.'!c“w % -/é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Ser… | 2002 |
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 |
|---|---|---|---|
| K052674 | Contact Lens Ophthalmodynamometer | 2006 | 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?
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 Haag-Streit Contact Glasses arc a family of diagnostic and therapeutic contact lenses use in the examination of the eye fundus, retina and irido-corneal and vitreous bodies and for the laser therapy of intraocular abnormalities.
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/K051103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051103: Haag-Streit Contact Glasses Stery Cup, Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051103
Report an extraction error
Are you the manufacturer?
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