Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HCA · Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
342 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161731 | Cleveland Multiport Ventricular Catheter Set | Parker Hannifin Corp. | 2017-03-27 | 277 | 0 |
| K123605 | SMARTFLOW CATHETER | Mri Interventions, Inc. | 2013-08-16 | 268 | 0 |
| K031123 | CODMAN BACTISEAL BARIUM STRIPED CATHETERS | Codman & Shurtleff, Inc. | 2003-05-14 | 35 | 1 |
| K021481 | BRESAGEN CATHETER, MODEL CS-3000 | Bresagen, Inc. | 2002-08-06 | 90 | 0 |
| K020728 | MIETHKE SHUNT SYSTEM | Aesculap, Inc. | 2002-04-05 | 30 | 1 |
| K013005 | ACT 11 MP VENTRICULAR CATHETER | Innerspace, Inc. | 2002-03-08 | 183 | 0 |
| K003322 | CODMAN BACTISEAL CATHETERS | Codman & Shurtleff, Inc. | 2001-10-01 | 342 | 0 |
| K992796 | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 | Image-Guided Neurologics, Inc. | 1999-10-25 | 67 | 0 |
| K983331 | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM | Medtronic PS Medical | 1998-12-16 | 85 | 29 |
| K834477 | DISPOS. SCOTT CANNULAS 16-1054 ETC. | Codman & Shurtleff, Inc. | 1984-03-19 | 90 | 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