Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cathlab Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
150 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910917 | CATHLAB SILICONE BILIARY BALLOON CATHETER | Cathlab Corp. | 1991-08-02 | 150 | 0 |
| K910916 | CATHLAB SILICONE OCCLUSION BALLOON CATHETER | Cathlab Corp. | 1991-06-24 | 111 | 0 |
| K905139 | CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER | Cathlab Corp. | 1991-02-25 | 108 | 0 |
| K897051 | MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH | Cathlab Corp. | 1990-03-16 | 88 | 0 |
| K897184 | 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS | Cathlab Corp. | 1990-03-14 | 76 | 0 |
| K893435 | SILICONE FLOW-DIRECTED THERMODILUTION CATHETER | Cathlab Corp. | 1989-09-26 | 147 | 0 |
| K893680 | SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. | Cathlab Corp. | 1989-08-01 | 77 | 0 |
| K881455 | EMBOLECTOMY CATHETER(MODIFIED) | Cathlab Corp. | 1988-06-15 | 70 | 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