Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Piccolo Medical, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical, Inc. | 2025-11-17 | 76 | 0 |
| K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | 2025-05-29 | 202 | 0 |
| K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | 2024-09-08 | 201 | 0 |
| K200037 | Piccolo Medical SmartPICC System | Piccolo Medical, Inc. | 2021-01-22 | 380 | 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