510(k) · Cleared
ClearedBoston RGP Lenses Wet Shipped in Bostom Simplus Multi-Action Solution and Stored for UP to 30 Days
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · HQD Lens, Contact (Other Material) - Daily
Cleared on Feb 21, 2008 as substantially equivalent to K002025 (Polymer Technology, 2000) after a 100-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Feb 21, 2008
- Review
- 100 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002025 (2000). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002025 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- This deviceK073184 Boston RGP Lenses Wet Shipped in Bostom Simplus Multi-Action…Bausch & Lomb, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK180988 Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58…Acuity Polymers, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK230965 Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97…Acuity Polymers, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens…Acuity Polymers, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK242393 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with…Acuity Polymers, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK241398 SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180988Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B)…Acuity Polymers, Inc. · 2018 · cites it directly5descendants
- K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™…Acuity Polymers, Inc. · 2023 · 2 generations on4descendants
- K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc. · 2024 · 3 generations on3descendants
- K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc. · 2024 · 4 generations on0descendants
- K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002025 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| 0 (this device) | K073184 | Boston RGP Lenses Wet Shipped in Bostom Simplus Multi-Action Solution and… | Bausch & Lomb, Inc. | 2008 | — |
| +1 | K180988 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58… | Acuity Polymers, Inc. | 2018 | — |
| +2 | K230965 | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with… | Acuity Polymers, Inc. | 2023 | — |
| +3 | K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™… | Acuity Polymers, Inc. | 2024 | — |
| +4 | K242393 | Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™… | Acuity Polymers, Inc. | 2024 | — |
| +4 | K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | Tianjin Mastervision Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 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 |
|---|---|---|---|
| * | K002025 | Rigid Gas Permeable Contact LensSummary page 2…l (not heat) disinfection system recommended in the labeling. 4. Substantial Equivalence 510(k) Clearance Date Device Description K002025 10/31/2000 BOSTON RGP Lenses Wet… | 2000 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180988 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B)… | 2018 | 5 |
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. 2008, 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?
BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), BOSTON ES (enflufocon A), BOSTON 7 (satafocon A), and BOSTON RXD (itabisfluorofocon A RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfecting system only. BOSTON IV(itafocon B), BOSTON II(itafocon A)RGP…
Read the full statement (112 words)
BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), BOSTON ES (enflufocon A), BOSTON 7 (satafocon A), and BOSTON RXD (itabisfluorofocon A RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfecting system only.
BOSTON IV(itafocon B), BOSTON II(itafocon A)RGP Contact Lenses are indicated for daily wear for the correction of visual acuity for non-aphakic persons with myopia, hyperopia, or keratoconus and for the correction of corneal astigmatism up to 4.00 diopters. The lens is disinfected using a chemical (not heat) disinfection system recommended in the labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073184 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073184: Boston RGP Lenses Wet Shipped in Bostom Simplus Multi-Action Solution and Stored for UP to 30 Days.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073184
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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