Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FKO — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
37 daysmedian FDA review time
605 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964514 | CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS | Corpak, Inc. | 1998-06-26 | 605 | 0 |
| K974570 | PERITONEAL DIALYSIS CATHETER CONNECTOR | Medigroup, Inc. | 1998-02-27 | 81 | 0 |
| K910787 | TITANIUM CONNECTOR (2 PART) | Accurate Surgical Instruments Co. | 1991-08-15 | 171 | 0 |
| K885037 | AMUKIN 50% - AIRSPRAY(R) | Bernard J. Cooney, P.A. | 1990-10-19 | 683 | 0 |
| K874650 | PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) | Quinton, Inc. | 1987-12-09 | 26 | 0 |
| K872221 | DIALY-NATE SET & DIALY-NATE CATHETER | Gesco Intl., Inc. | 1987-10-13 | 126 | 0 |
| K871730 | MODIFIED USE OF PULL-APART INTRODUCER SET | Quinton, Inc. | 1987-05-18 | 13 | 0 |
| K870472 | ACUTE PERITONEAL DIALYSIS KIT | Quinton, Inc. | 1987-02-25 | 22 | 0 |
| K860155 | PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 | Medical Components, Inc. | 1986-02-14 | 29 | 0 |
| K854966 | ACUTE PERITONEAL DIALYSIS CATHETERS | Thermedics, Inc. | 1986-01-09 | 29 | 0 |
| K845041 | CAPD STAGED CONNECTOR | Abbott Laboratories | 1985-02-21 | 55 | 0 |
| K813336 | LAZARUS-NELSON PERITONEAL LAVAGE TRAY | American Pharmaseal Div. Ahsc | 1981-12-18 | 24 | 0 |
| K812717 | NON-STERILE SHADOW-STRIPE CATHETER | Quinton, Inc. | 1981-10-19 | 24 | 0 |
| K811266 | QUINTON CATHETER FINGER GRIP | Quinton, Inc. | 1981-06-18 | 37 | 0 |
| K802954 | DRESSING CHANGE TRAY-MEDIUM | Associated Medical Products Co. | 1980-12-17 | 27 | 0 |
| K760544 | CATHETER, PERITONEAL DIALYSIS | Travenol Laboratories, S.A. | 1976-10-20 | 51 | 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