510(k) · Cleared
ClearedBoston EO Rigid Gas Permeable Contact Lens Material (Enflofocon B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Div. Wilmington Partners, L.P. · HQD Lens, Contact (Other Material) - Daily
Cleared on May 11, 1998 as substantially equivalent to K943177 (Polymer Technology Corp., 1994) after a 74-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- May 11, 1998
- Review
- 74 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943177 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- This deviceK980741 Boston EO Rigid Gas Permeable Contact Lens Material (Enflofocon B)Polymer Technology Div. Wilmington Partners, L.P. · 1998
- Descendant · cites it directly · 0 of its ownK170007 Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170007Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| 0 (this device) | K980741 | Boston EO Rigid Gas Permeable Contact Lens Material (Enflofocon B) | Polymer Technology Div. Wilmington Partners, L.P. | 1998 | — |
| +1 | K170007 | Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K943177 | Boston (R) 7 - 30(Enflufocon a)Summary page 3…ON ES. 8. SUBSTANTIAL EQUIVALENCE The BOSTON EQ is substantially equivalent to the currently marketed BOSTON ES, which was cleared in 510(k) Premarket Notification No. K943177 on August 25, 1994, The difference between the two devices is a change in the component ratios. 4, 4 EALT) o ¥ H… | 1994 |
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 |
|---|---|---|---|
| K170007 | Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens | 2017 | 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 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?
BOSTON EO (enflufocon B) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
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/K980741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980741: Boston EO Rigid Gas Permeable Contact Lens Material (Enflofocon B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980741
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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