Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Igel Vision Care Pte , Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021907 | IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LEN | Igel Vision Care Pte , Ltd. | 2002-09-04 | 86 | 0 |
| K020855 | IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FO | Igel Vision Care Pte , Ltd. | 2002-06-04 | 81 | 0 |
| K984523 | IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS | Igel Vision Care Pte , Ltd. | 1999-02-16 | 57 | 0 |
| K974837 | IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS | Igel Vision Care Pte , Ltd. | 1998-07-06 | 194 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda