510(k) · Cleared
ClearedUltracon/Ultracon S Rigid Gas Permeable Contact Lens for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialty Ultravision, Inc. · HQD Lens, Contact (Other Material) - Daily
Cleared on Aug 4, 1998 as substantially equivalent to K963010 (Permeable Technologies, Inc., 1996) after a 196-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Aug 4, 1998
- Review
- 196 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963010 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK963010 Lifestyle GP (Telefocon B) Rigid Gas Permeable Multifocal Contact…Permeable Technologies, Inc. · 1996
- This deviceK980197 Ultracon/Ultracon S Rigid Gas Permeable Contact Lens for Daily WearSpecialty Ultravision, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK992787 Epicon (Carbosilfocon a) Rigid Gas Permeable Contact Lens Daily WearSpecialty Ultravision, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K992787Epicon (Carbosilfocon a) Rigid Gas Permeable Contact Lens Daily WearSpecialty Ultravision, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963010 | Lifestyle GP (Telefocon B) Rigid Gas Permeable Multifocal Contact Lens for… | Permeable Technologies, Inc. | 1996 | — |
| 0 (this device) | K980197 | Ultracon/Ultracon S Rigid Gas Permeable Contact Lens for Daily Wear | Specialty Ultravision, Inc. | 1998 | — |
| +1 | K992787 | Epicon (Carbosilfocon a) Rigid Gas Permeable Contact Lens Daily Wear | Specialty Ultravision, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 HQD? 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 HQD device
- #1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K963010 | Lifestyle GP (Telefocon B) Rigid Gas Permeable Multifocal Contact Lens for Daily WearSummary page 1…CFR 886.5916) Predicate Device: The predicate device is the LifeStyle GP (telefocon B) Rigid Gas Permeable Contact Lens for Daily Wear, which was cleared under 510(k) K963010. This device was selected as the predicate device because of its similarities in intended use (daily wear), Dk value, and materia… | 1996 |
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 |
|---|---|---|---|
| K992787 | Epicon (Carbosilfocon a) Rigid Gas Permeable Contact Lens Daily Wear | 2000 | 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?
- Its one ancestor has no recall.
- Of its descendants, K992787 (Specialty Ultravision, Inc., 2000) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HQD devicesHQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQD
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HQD
80in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQD
2in 2025
MAUDE reports naming product code HQD, 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 | 4 | 78 | 0 | 6 |
| 2008 | 5 | 100 | 0 | 8 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 0 | 26 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 7 | 119 | 0 | 1 |
| 2017 | 9 | 66 | 0 | 3 |
| 2018 | 5 | 53 | 0 | 0 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 3 | 123 | 0 | 3 |
| 2022 | 3 | 29 | 0 | 3 |
| 2023 | 3 | 77 | 0 | 8 |
| 2024 | 5 | 80 | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 4.00 diopters. The lenses may be disinfected using a chemical disinfection system.
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/K980197 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980197: Ultracon/Ultracon S Rigid Gas Permeable Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980197
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