Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Accu-Line — 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) |
|---|---|---|---|---|---|
| K831847 | JEJUNOSTOMY KIT | Accu-Line | 1983-08-31 | 84 | 0 |
| K831636 | PERCUTANEOUS INTRODUCER KIT | Accu-Line | 1983-08-24 | 93 | 0 |
| K831637 | ACCU-FLUSH | Accu-Line | 1983-06-30 | 38 | 0 |
| K830298 | ACCU-LINE SURGICAL MARKER | Accu-Line | 1983-06-02 | 125 | 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