510(k) Report

510(k) · Cleared

Cleared

Paflufocon a, B, C & D

K940277510(k) TraditionalCleared May 9, 1994110-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

Paragon Vision Sciences · HQD Lens, Contact (Other Material) - Daily

Cleared on May 9, 1994 after a 110-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 35 later devices descend from it.

Decided
May 9, 1994
Review
110 days
Class
Class II
Product code
HQD
Recalls
None
Predicates
0

35 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 2 descendants cleared2006: 2 descendants cleared2016: 6 descendants cleared2009: 1 descendant cleared2014: 1 descendant cleared2021: 3 descendants cleared2018: 2 descendants cleared2017: 3 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2024: 5 descendants cleared2026: 1 descendant cleared2023: 3 descendants cleared1990200020102020
  1. This deviceK940277 Paflufocon a, B, C & DParagon Vision Sciences · 1994
  2. Descendant · cites it directly · 28 of its ownK033594 Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · Recalled
  3. Descendant · 2 generations on · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
  4. Descendant · 3 generations on · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
  5. Descendant · 4 generations on · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
  6. Descendant · 5 generations on · 9 of its ownK180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens…Contamac, Ltd. · 2018

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 22009: 12014: 12016: 62017: 32018: 22019: 22021: 32022: 32023: 32024: 52026: 1
2004high 6 (2016) · low 0 (2007)2026

Most influential descendants

Showing 5 of 35 · See all
  • K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · cites it directly28descendants
  • 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
0 (this device)K940277Paflufocon a, B, C & DParagon Vision Sciences1994—
+1K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd.20042
+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
200410
200520
200620
200910
201410
201660
201730
201820
201920
202130
202230
202330
202450
202610
FIG. 1 — Lineage of K940277, 1994–2026Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (35)

See all 35

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd.200428
K051035Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact LensSynergeyes20055
K052675Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for KeratoconusSynergeyes20053
K060102Synergeyes PS Hybrid Contact LensSynergeyes, Inc.20062

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?

  • Of its descendants, K033594 (Contamac, Ltd., 2004) has gone furthest, with 28 descendants of its own.

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—

More from Paragon Vision Sciences

68 FDA decisions under this applicant name. See the company

  • K180172FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 &…Paragon Vision Sciences · 2018
  • K120996Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92 Fluoroperm 151 Paragon ThinParagon Vision Sciences · 2012
  • K082799HDS HI 1.54Paragon Vision Sciences · 2009
  • K070637Fluoroperm 92, 60, 30 and 151 and Paragon HDS, HDS 100 and Thin Rigid Gas Permeable Contact LensesParagon Vision Sciences · 2007
  • K052983Fluoroperm 151 (Paflufocon D) and Paragon HDS 100 (Paflufocon D) Rigid Gas Permeable Contact LensesParagon Vision Sciences · 2006

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/K940277 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940277: Paflufocon a, B, C & D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940277

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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