510(k) · Cleared
ClearedOxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon Vision Sciences, Inc. · HQD Lens, Contact (Other Material) - Daily
Cleared on May 5, 2023 as substantially equivalent to K171404 (Bausch + Lomb, Incorporated, 2017) after a 322-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- May 5, 2023
- Review
- 322 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K943177 (1994). 20 ancestors in all, the oldest P860022 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 7 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 6 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- 5 generations backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- 4 generations backK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
- 3 generations backK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
- 2 generations backK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
- 1 generation backK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
- This deviceK221768 Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesParagon Vision Sciences, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −7 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −6 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| −5 | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| −4 | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Inc. | 2007 | 2 |
| −3 | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | 2016 | — |
| −2 | K161461 | BostonSight PD Prosthetic Device | Bostonsight | 2016 | 1 |
| −1 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017 | — |
| 0 (this device) | K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | Paragon Vision Sciences, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Summary page 4…3. PREDICATE DEVICES The Oxfore®100 (hexafocon A) RGP contact lenses for daily wear are substantially equivalent to the Boston XO™ (hexafocon A) Daily Wear Contact Lens (K171404) in terms of the following: • Intended Use – daily wear contact lenses • Actions • Classifications – Lenses, R… | 2017 |
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?
- The line of descent spans 29 years and passes through 9 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 20 ancestors have a recall of any class.
- 4 other devices also cite its predicate K171404.
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. 2023, this device’s year, is highlighted.
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 Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221768: Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221768
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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