510(k) Report

510(k) · Cleared

Cleared

H55 Hydrophilic Contact Lens

K942214510(k) TraditionalCleared Jul 28, 199483-day reviewClass II21 CFR 886.5925

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

Martin S. Knopf Assoc., Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Jul 28, 1994 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided
Jul 28, 1994
Review
83 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 3 descendants cleared1997: 1 descendant cleared2009: 2 descendants cleared2003: 2 descendants cleared2002: 1 descendant cleared2001: 2 descendants cleared2010: 1 descendant cleared2018: 3 descendants cleared2016: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2025: 2 descendants cleared2021: 1 descendant cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK942214 H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994
  2. Descendant · cites it directly · 21 of its ownK972303 Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997
  3. Descendant · cites it directly · 15 of its ownK984046 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999
  4. Descendant · cites it directly · 13 of its ownK982947 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 1999
  5. Descendant · 2 generations on · 11 of its ownK020193 Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft…Cl Mcintosh · 2002
  6. Descendant · 2 generations on · 10 of its ownK012425 Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc. · 2001

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

1997: 11999: 32001: 22002: 12003: 22009: 22010: 12014: 12015: 12016: 12018: 32019: 12021: 12025: 2
1997high 3 (1999) · low 0 (1998)2026

Most influential descendants

Showing 5 of 22 · See all
  • K972303Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997 · cites it directly21descendants
  • K984046Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999 · cites it directly15descendants
  • K982947Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 1999 · cites it directly13descendants
  • K020193Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact LensCl Mcintosh · 2002 · 2 generations on11descendants
  • K012425Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc. · 2001 · 2 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942214H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc.1994—
+1K972303Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc.1997—
+1K984046Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc.1999—
+1K982947Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc.1999—
+2K020193Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic)…Cl Mcintosh2002—
+2K012425Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199930
200120
200210
200320
200920
201010
201410
201510
201610
201830
201910
202110
202520
FIG. 1 — Lineage of K942214, 1994–2025Source: 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 LPL? 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 LPL device

  1. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K972303Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc.199721
K984046Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc.199915
K982947Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc.199913
K992264Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc.19991

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, K972303 (Ocular Sciences Puerto Rico, Inc., 1997) has gone furthest, with 21 descendants of its own.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

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

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

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

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, 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
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

More from Martin S. Knopf Assoc., Inc.

2 FDA decisions under this applicant name. See the company

  • K910532Uram Ophthalmic Laser EndoscopeMartin S. Knopf Assoc., Inc. · 1991

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K942214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942214: H55 Hydrophilic Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942214

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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