Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Percutaneous Systems, Incorporated — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
476 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090485 | COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, | Percutaneous Systems, Incorporated | 2009-07-22 | 147 | 0 |
| K061766 | EXPRESSWAY INTERMITTENT CATHETER | Percutaneous Systems, Incorporated | 2007-03-09 | 260 | 0 |
| K052298 | CYSTOGLIDE INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2006-12-12 | 476 | 0 |
| K052048 | ACCORDION | Percutaneous Systems, Incorporated | 2005-09-13 | 46 | 0 |
| K042531 | UPDATED SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2005-02-01 | 137 | 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