Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KYT — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
83 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920782 | OLYMPIC TRANS-LITE | Olympic Medical Corp. | 1992-03-27 | 36 | 0 |
| K841588 | SUN-LITE WHITE SPOT | Suncoast Medical Manufacturers, Inc. | 1984-05-22 | 34 | 0 |
| K841589 | C-LITE | Suncoast Medical Manufacturers, Inc. | 1984-05-22 | 34 | 0 |
| K791001 | PENLIGHT/SWAB HOLDER | Concept, Inc. | 1979-06-22 | 24 | 0 |
| K781228 | PENLIGHTS | Abco Dealers, Inc. | 1978-09-07 | 52 | 0 |
| K760972 | TYCOS DIAGNOSTIC PENLIGHT | Taylor Instrument Analytics Co. | 1977-01-26 | 83 | 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