Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KTG — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
32 daysmedian FDA review time
38 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K822280 | ENT KNIFE HANDLES | Kelleher Corp. | 1982-08-30 | 32 | 0 |
| K822205 | KNIVES, ENT | Kelleher Corp. | 1982-08-30 | 38 | 0 |
| K822279 | LANCETS FOR EAR SURGERY | Kelleher Corp. | 1982-08-25 | 27 | 0 |
| K822187 | TONSIL DISSECTORS | Kelleher Corp. | 1982-08-24 | 32 | 0 |
| K822203 | KNIFE HANDLE | Kelleher Corp. | 1982-08-20 | 28 | 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