Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
iSMART Developments, 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) |
|---|---|---|---|---|---|
| K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | 2026-07-24 | 150 | 0 |
| K250224 | handLITE (TN19S) | iSMART Developments, Ltd. | 2025-04-18 | 81 | 0 |
| K242382 | décoLITE LED Device | iSMART Developments, Ltd. | 2024-11-08 | 88 | 0 |
| K231555 | LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2 | iSMART Developments, Ltd. | 2023-07-27 | 58 | 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