510(k) · Cleared

Cleared

Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens

K972303510(k) TraditionalCleared Aug 20, 199762-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

Ocular Sciences Puerto Rico, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Aug 20, 1997 as substantially equivalent to K942214 (Martin S. Knopf Assoc., Inc., 1994) after a 62-day review. Its family tree reaches back 1 generation to 1994. 21 later devices descend from it.

Decided: Aug 20, 1997
Review: 62 days
Class: Class II
Product code: LPL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K942214 (1994). 21 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK942214 H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994
This deviceK972303 Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997
Descendant · cites it directly · 15 of its ownK984046 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999
Descendant · cites it directly · 13 of its ownK982947 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 1999
Descendant · 2 generations on · 11 of its ownK020193 Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft…Cl Mcintosh · 2002
Descendant · 2 generations on · 10 of its ownK012425 Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc. · 2001
Descendant · 3 generations on · 9 of its ownK091339 Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010 · Recalled

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1999high 3 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 21 · See all

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
K091339Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010 · 3 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K942214	H55 Hydrophilic Contact Lens	Martin S. Knopf Assoc., Inc.	1994	—
0 (this device)	K972303	Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens	Ocular Sciences Puerto Rico, Inc.	1997	—
+1	K984046	Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens	Ocular Sciences Puerto Rico, Inc.	1999	—
+1	K982947	Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens	Ocular Sciences Puerto Rico, Inc.	1999	—
+2	K020193	Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic)…	Cl Mcintosh	2002	—
+2	K012425	Biomedics UV Multifocal	Ocular Sciences Puerto Rico, Inc.	2001	—
+3	K091339	Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens	CooperVision, Inc.	2010	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	3	0
2001	2	0
2002	1	0
2003	2	0
2009	2	0
2010	1	0
2014	1	0
2015	1	0
2016	1	0
2018	3	0
2019	1	0
2021	1	0
2025	2	0

FIG. 1 — Lineage of K972303, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K942214	H55 Hydrophilic Contact Lens Summary page 1 …ufilcon D) visibility tint Ocular Sciences/ American Hydron contact lens with in-monomer tint is equivalent to the tinted daily wear lens of the same material cleared in K942214 for daily wear and is identical to the in-monomer tinted ocufilcon D contact lens approved in PMA P890023/54 for extended wear cu…	Martin S. Knopf Assoc., Inc.	1994	—
†	P890023	H55 Hydrophilic Contact Lens	The Cooper Companies	1989	1

Also cleared against K942214: 3 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K984046	Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens	Ocular Sciences Puerto Rico, Inc.	1999	15
K982947	Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens	Ocular Sciences Puerto Rico, Inc.	1999	13
K082879	Ezvue (Ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily Wear	I-See Vision Technology, Inc.	2009	4
K992264	Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft Contact Lens	Ocular Sciences Puerto Rico, Inc.	1999	1
K082880	Ezvue (Ocufilcon D) 1-Day Soft (Hydrophilic)Contact Lens	I-See Vision Technology, Inc.	2009	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?

Its one ancestor has no recall.
Of its descendants, K984046 (Ocular Sciences Puerto Rico, Inc., 1999) has gone furthest, with 15 descendants of its own.
3 other devices also cite its predicate K942214.

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

2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007high 281 (2007) · low 56 (2018)2026

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

Recalls per year · LPL

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	281	1	280
2008	10	104	0	214
2009	6	260	1	137
2010	9	244	0	222
2011	12	170	5	377
2012	12	131	1	250
2013	17	135	0	151
2014	15	102	1	179
2015	12	120	1	161
2016	21	112	0	193
2017	9	98	11	280
2018	21	56	0	257
2019	11	115	0	205
2020	10	158	1	117
2021	8	88	0	110
2022	9	212	1	126
2023	10	167	0	178
2024	12	128	0	297
2025	12	202	1	216
2026	10	90	1	—

What is it indicated for?

The Hydron Biomedics 55 (ocufilcon D) visibility tint soft (hydrophilic) contact lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit astigmatism of 2.00 D or less that does not interfere with visual acuity; it is available in powers from -10 to + 10 diopters.

Eyecare practitioners may prescribe the lens for either single-use disposable wear or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement (see WEARING SCHEDULE). When prescribed for frequent/ planned replacement wear, the lens may be disinfected using a chemical disinfection system.

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/K972303 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972303: Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972303

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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