510(k) · Cleared
ClearedIgel (R) 56 (Hefilcon C) Soft (Hydrophlic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Igel Vision Care Pte, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jul 6, 1998 after a 194-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jul 6, 1998
- Review
- 194 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK974837 Igel (R) 56 (Hefilcon C) Soft (Hydrophlic) Contact LensIgel Vision Care Pte, Ltd. · 1998
- Descendant · cites it directly · 1 of its ownK984090 Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact…Specialty Ultravision, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK993580 Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for…Specialty Ultravision, Inc. · 2000
Most influential descendants
Showing 2 of 2 · See all- K984090Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily…Specialty Ultravision, Inc. · 1999 · cites it directly1descendant
- K993580Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily WearSpecialty Ultravision, Inc. · 2000 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974837 | Igel (R) 56 (Hefilcon C) Soft (Hydrophlic) Contact Lens | Igel Vision Care Pte, Ltd. | 1998 | — |
| +1 | K984090 | Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lenses for… | Specialty Ultravision, Inc. | 1999 | — |
| +2 | K993580 | Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear | Specialty Ultravision, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 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 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
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 |
|---|---|---|---|
| * | — | Gold Medalist Toric lenses Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984090 | Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily… | 1999 | 1 |
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, K984090 (Specialty Ultravision, Inc., 1999) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 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 Igel®56 (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfecting systems only.
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/K974837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974837: Igel (R) 56 (Hefilcon C) Soft (Hydrophlic) 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/K974837
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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