Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Catheter Research C/O Burditt, Bowles & Radzius · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
234 daysmedian FDA review time
312 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924227 | CRI CYNOSAR CATHETER | Catheter Research C/O Burditt, Bowles & Radzius | 1993-06-29 | 312 | 0 |
| K924125 | CRI ELECTRONIC CONTROL SYSTEM | Catheter Research C/O Burditt, Bowles & Radzius | 1993-05-26 | 282 | 0 |
| K914523 | CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL | Catheter Research C/O Burditt, Bowles & Radzius | 1992-01-10 | 92 | 0 |
| K904785 | CRI CYNOSAR CATHETER | Catheter Research C/O Burditt, Bowles & Radzius | 1991-03-06 | 135 | 0 |
| K904787 | CRI STEERABLE CATHETER CONTROL SYSTEM | Catheter Research C/O Burditt, Bowles & Radzius | 1990-12-17 | 55 | 0 |
| K900320 | CRI CYNOSAR CATHETER | Catheter Research C/O Burditt, Bowles & Radzius | 1990-09-14 | 234 | 0 |
| K884337 | MICRO-GUIDE SYSTEM | Catheter Research C/O Burditt, Bowles & Radzius | 1989-01-05 | 83 | 0 |
| K870700 | MICRO-GUIDE | Catheter Research C/O Burditt, Bowles & Radzius | 1987-12-03 | 287 | 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