510(k) · Cleared
ClearedAcuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuity Polymers, Inc. · HQD Lens, Contact (Other Material) - Daily
Cleared on Sep 8, 2020 as substantially equivalent to K162005 (Acuity Polymers, Inc., 2016) after a 127-day review. Its family tree reaches back 6 generations to 1994. 7 later devices descend from it.
- Decided
- Sep 8, 2020
- Review
- 127 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943177 (1994). 9 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 5 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 4 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- 3 generations backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- 2 generations backK071043 Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES…Bausch & Lomb, Inc. · 2007 · Recalled
- 1 generation backK162005 Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2016
- This deviceK201194 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK203571 Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK233325 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E…Visionary Optics, LLC · 2024
- Descendant · cites it directly · 4 of its ownK213538 Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas…Acuity Polymers, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens…Acuity Polymers, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242393 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with…Acuity Polymers, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021 · cites it directly6descendants
- K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC · 2024 · 2 generations on4descendants
- K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021 · cites it directly4descendants
- K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc. · 2024 · cites it directly3descendants
- K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −5 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −4 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| −3 | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| −2 | K071043 | Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a)… | Bausch & Lomb, Inc. | 2007 | 2 |
| −1 | K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2016 | — |
| 0 (this device) | K201194 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2020 | — |
| +1 | K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2021 | — |
| +2 | K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon… | Visionary Optics, LLC | 2024 | — |
| +1 | K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable… | Acuity Polymers, Inc. | 2021 | — |
| +1 | K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™… | Acuity Polymers, Inc. | 2024 | — |
| +2 | K242393 | Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™… | Acuity Polymers, Inc. | 2024 | — |
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 |
|---|---|---|
| 2021 | 2 | 0 |
| 2024 | 5 | 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 |
|---|---|---|---|
| * | K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensSummary page 4…Device Product Code: HQD PREDICATE DEVICE Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (K162005). DEVICE DESCRIPTION The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is manufactured from a mac… | 2016 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | 2021 | 6 |
| K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | 2021 | 4 |
| K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon… | 2024 | 3 |
| K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | 2024 | 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?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K203571 (Acuity Polymers, Inc., 2021) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K162005.
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. 2020, 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear and for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear.
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/K201194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201194: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201194
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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