510(k) · Cleared
Recalled · 2010Boston (R) 7 - 30(Enflufocon a)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Corp. · HQD Lens, Contact (Other Material) - Daily
Cleared on Aug 25, 1994 after a 55-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 54 later devices descend from it. It has been recalled once.
- Decided
- Aug 25, 1994
- Review
- 55 days
- Class
- Class II
- Product code
- HQD
- Recalls
- 1
- Predicates
- 0
54 later devices descend from it, 6 citing it directly.
- This deviceK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994
- Descendant · cites it directly · 50 of its ownK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- Descendant · cites it directly · 39 of its ownK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- Descendant · 2 generations on · 38 of its ownK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- Descendant · cites it directly · 30 of its ownK970698 Boston ES Multivision (Enflufocon a) Contact LensPolymer Technology Corp. · 1997
- Descendant · 2 generations on · 28 of its ownK033594 Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · Recalled
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K000795Rigid Gas Permeable Contact LensPolymer Technology · 2000 · cites it directly50descendants
- K020006Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002 · cites it directly39descendants
- K053124Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas…Bausch & Lomb, Incorporated · 2006 · 2 generations on38descendants
- K970698Boston ES Multivision (Enflufocon a) Contact LensPolymer Technology Corp. · 1997 · cites it directly30descendants
- K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · 2 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | — |
| +1 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| +1 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| +2 | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| +1 | K970698 | Boston ES Multivision (Enflufocon a) Contact Lens | Polymer Technology Corp. | 1997 | — |
| +2 | K033594 | Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses | Contamac, Ltd. | 2004 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (54)
See all 546 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K000795 | Rigid Gas Permeable Contact Lens | 2000 | 50 |
| K020006 | Dyna Intra-Limbal Lens | 2002 | 39 |
| K970698 | Boston ES Multivision (Enflufocon a) Contact Lens | 1997 | 30 |
| K171575 | ENFLU 18 (enflufocon A) Daily Wear Contact Lens | 2017 | 1 |
| K980741 | Boston EO Rigid Gas Permeable Contact Lens Material (Enflofocon B) | 1998 | 1 |
| K163254 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2010 | Not classified | Z-1705-2010 | Process control | The amount of D&C #6 Dye added to the formulation exceeded specified amounts. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K000795 (Polymer Technology, 2000) has gone furthest, with 50 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 | — |
https://510kreport.com/device/K943177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943177: Boston (R) 7 - 30(Enflufocon a).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943177
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026