Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MAJ · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
193 daysmedian FDA review time
583 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K965251 | MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM | Medtronic Vascular | 1997-03-18 | 89 | 0 |
| K945413 | MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHE | Medtronic Vascular | 1995-05-24 | 202 | 0 |
| K934939 | TEMPORARY SCREENING LEAD/ CATHETER KIT | Medtronic Vascular | 1995-05-24 | 583 | 0 |
| K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | Concord/Portex | 1993-07-27 | 193 | 0 |
| K911382 | IPI ALGO-LINE CATHETER | Pudenz-Schulte Medical Research Corp. | 1991-07-18 | 112 | 0 |
| K893766 | LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE | Abbott Laboratories | 1989-11-01 | 166 | 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