510(k) Report

510(k) · Cleared

Cleared

Rigid Gas Permeable Contact Lens Solution

K011945510(k) TraditionalCleared Sep 12, 200183-day reviewClass II21 CFR 886.5916

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Polymer Technology Corp. · HQD Lens, Contact (Other Material) - Daily

Cleared on Sep 12, 2001 as substantially equivalent to K002025 (Polymer Technology, 2000) after an 83-day review. Its family tree reaches back 1 generation to 2000. 27 later devices descend from it.

Decided
Sep 12, 2001
Review
83 days
Class
Class II
Product code
HQD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002025 (2000). 27 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2018: 3 descendants cleared2019: 2 descendants cleared2012: 1 descendant cleared2016: 3 descendants cleared2011: 1 descendant cleared2024: 5 descendants cleared2023: 3 descendants cleared2017: 2 descendants cleared2022: 3 descendants cleared2021: 2 descendants cleared2026: 1 descendant clearedK002025 · Rigid Gas Permeable Contact Lens · Polymer Technology · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 6 descendants5 generations forward: 10 descendants K002025 · Rigid Gas Permeable Contact Lens · Polymer Technology · 20000+5
  1. Root · 1 generation backK002025 Rigid Gas Permeable Contact LensPolymer Technology · 2000
  2. This deviceK011945 Rigid Gas Permeable Contact Lens SolutionPolymer Technology Corp. · 2001
  3. Descendant · cites it directly · 26 of its ownK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
  4. Descendant · 2 generations on · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
  5. Descendant · 3 generations on · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
  6. Descendant · 4 generations on · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
  7. Descendant · 5 generations on · 9 of its ownK180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens…Contamac, Ltd. · 2018

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2007: 12011: 12012: 12016: 32017: 22018: 32019: 22021: 22022: 32023: 32024: 52026: 1
2007high 5 (2024) · low 0 (2008)2026

Most influential descendants

Showing 5 of 27 · See all
  • K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · cites it directly26descendants
  • K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016 · 2 generations on20descendants
  • K161461BostonSight PD Prosthetic DeviceBostonsight · 2016 · 3 generations on19descendants
  • K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017 · 4 generations on14descendants
  • K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A)…Contamac, Ltd. · 2018 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002025Rigid Gas Permeable Contact LensPolymer Technology2000—
0 (this device)K011945Rigid Gas Permeable Contact Lens SolutionPolymer Technology Corp.2001—
+1K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc.20072
+2K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight2016—
+3K161461BostonSight PD Prosthetic DeviceBostonsight20161
+4K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated2017—
+5K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100…Contamac, Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201110
201210
201630
201720
201830
201920
202120
202230
202330
202450
202610
FIG. 1 — Lineage of K011945, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K002025Rigid Gas Permeable Contact Lens
Summary page 1
…al 4. PREDICATE DEVlgE: BOSTON XO (hexafocon A) RGP Contact Lenses Wet Shipped and up to 30 day storage in Boston Advance Comfort Formula Conditioning Solution, 510(k) K002025 cleared on October 31, 2000. 5. DESCRIPTION OF THE DEVICE: BOSTON EQUALENS (itafluorofocon A) and EQUALENS Il (oprifocon A) Con…
Polymer Technology2000—

Also cleared against K002025: 2 other devices →

What descends from it? (27)

See all 27

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc.200726

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?

  • Its one ancestor has no recall.
  • Of its descendants, K071266 (Bausch & Lomb, Inc., 2007) has gone furthest, with 26 descendants of its own.
  • 2 other devices also cite its predicate K002025.

How does its category compare?

All HQD devices

HQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQD

5in 2024

2007: 42008: 52009: 22011: 22012: 22014: 12016: 72017: 92018: 52019: 22020: 12021: 32022: 32023: 32024: 52026 (partial year): 1
2007high 9 (2017) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQD

80in 2024

2007: 78 days median2008: 100 days median2016: 119 days median2017: 66 days median2018: 53 days median2021: 123 days median2022: 29 days median2023: 77 days median2024: 80 days median
2007high 123 (2021) · low 29 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HQD

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQD

2in 2025

2007: 62008: 82009: 122010: 22011: 72012: 102013: 152014: 262015: 52016: 12017: 32019: 52020: 22021: 32022: 32023: 82024: 32025: 2
2007high 26 (2014) · low 0 (2018)2025

MAUDE reports naming product code HQD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200747806
2008510008
20092—012
20100—12
20112—07
20122—010
20130—015
20141—026
20150—05
2016711901
201796603
201855300
20192—05
20201—02
2021312303
202232903
202337708
202458003
20250—02
20261—0—

What is it indicated for?

BOSTON EQUALENS (itafluorofocon A) and BOSTON EQUALENS Ii (oprifocon 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 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.

Also cleared against K002025

2 other devices cite the same predicate.

  • K073184Boston RGP Lenses Wet Shipped in Bostom Simplus Multi-Action Solution and Stored for UP to 30 DaysBausch & Lomb, Inc. · 2008
  • K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 20042 recalls

More from Polymer Technology Corp.

120 FDA decisions under this applicant name. See the company

  • K980133Bausch & Lomb Wetting and Soaking SolutionPolymer Technology Corp. · 1998
  • K974466Boston Advance CleanerPolymer Technology Corp. · 1998
  • K973217Boston Liquid Enzymatic CleanerPolymer Technology Corp. · 1997
  • K970698Boston ES Multivision (Enflufocon a) Contact LensPolymer Technology Corp. · 1997
  • K951552Boston Contact Lens CasePolymer Technology Corp. · 1995

Recent decisions in HQD

The HQD category page

  • K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd. · 2026
  • K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable…Acuity Polymers, Inc. · 2024
  • K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. · 2024
  • K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight · 2024
  • K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas…Acuity Polymers, Inc. · 2024

https://510kreport.com/device/K011945 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011945: Rigid Gas Permeable Contact Lens Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011945

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026