Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Percutaneous Systems, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
228 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102887 | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC38145 | Percutaneous Systems, Inc. | 2011-05-16 | 228 | 0 |
| K082803 | COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 | Percutaneous Systems, Inc. | 2008-11-13 | 50 | 0 |
| K052134 | CYSTOGLIDE DILATING INTRODUCER SHEATH | Percutaneous Systems, Inc. | 2005-09-22 | 48 | 0 |
| K042877 | MICROVERTER URETERAL ACCESS SHEATH | Percutaneous Systems, Inc. | 2004-11-16 | 29 | 0 |
| K040520 | SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Inc. | 2004-05-20 | 83 | 0 |
| K040519 | SLIP UROLOGY CATHETER | Percutaneous Systems, Inc. | 2004-05-20 | 83 | 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