Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

PNG — Predicate Candidate Screening

15 FDA 510(k) clearances under this product code; the 50 most recent screened below.

141 daysmedian FDA review time
291 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241278ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc.2025-01-142530
K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (Bard Peripheral Vascular, Inc.2024-12-061560
K230319Passio Pump Drainage SystemBearpac Medical2023-11-242910
K221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc.2023-05-023150
K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.2021-12-1411213
K201155PleurX Peritoneal Catheter SystemCare Fusion2020-10-211740
K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc2016-11-14730
K160437PleurX Peritoneal Catheter SystemCare Fusion2016-11-032600
K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetRocket Medical Plc2016-03-292440
K122422PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLCare Fusion2012-10-24760
K113854PLEURX PERITONEAL CATHETER SYSTEMCare Fusion2012-03-19810
K110396ASPIRA PERITONEAL DRAINAGE SYSTEMC.R. Bard, Inc.2011-05-068417
K093796ASEPT PERITONEAL DRAINAGE SYSTEMPfm Medical, Inc.2010-02-26771
K081288ASPIRA PERITONEAL DRAINAGE SYSTEMC.R. Bard, Inc.2008-07-18720
K051711PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITSDenver Biomedical, Inc.2005-11-151410

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