Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ONE · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
146 daysmedian FDA review time
504 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250224 | handLITE (TN19S) | iSMART Developments, Ltd. | 2025-04-18 | 81 | 0 |
| K171055 | Philips BlueControl | Philips Electronics Nederland B.V. | 2017-07-06 | 87 | 0 |
| K103415 | TANDA MAX | Pharos Life Corporation | 2011-01-03 | 42 | 0 |
| K100628 | PLASMALUXLS | Daavlin Distributing Co. | 2010-11-24 | 264 | 0 |
| K091467 | BABY QUASAR | Silver Bay, LLC | 2010-09-17 | 487 | 0 |
| K091125 | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 | Verilux | 2010-09-03 | 504 | 0 |
| K092800 | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL | Led Intellectual Properties, LLC | 2010-02-04 | 146 | 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