Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DQR — Predicate Candidate Screening
25 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
212 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131446 | INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES | Integra LifeSciences Corporation | 2013-10-28 | 161 | 0 |
| K073559 | 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIA | Edwards Lifesciences Research Medical | 2008-01-31 | 43 | 2 |
| K051655 | ANGIODYNAMICS, INC., MICRO ACCESS KITS | AngioDynamics, Inc. | 2005-09-12 | 83 | 1 |
| K030398 | CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 | Cardiacassist, Inc. | 2003-05-23 | 106 | 0 |
| K960098 | RMI INTERNAL MAMMARY ARTERY CANNULA | Research Medical, Inc. | 1996-03-26 | 75 | 0 |
| K902674 | DATASCOPE ARTERIAL CANNULA W/ACCESS PORT | Datascope Corp. | 1991-01-16 | 212 | 0 |
| K894784 | MODIFIED SHILEY FEMORAL VENOUS CANNULA | Shiley, Inc. | 1990-03-28 | 247 | 0 |
| K894243 | RMI ARTERIAL PERFUSION CANNULA | Research Medical, Inc. | 1989-09-19 | 90 | 0 |
| K884628 | HARBORIN CENTRAL VENOUS CATHETER | Harbor Medical Devices, Inc. | 1989-05-15 | 189 | 0 |
| K884478 | DAIG COLLAPSIBLE STERILE SLEEVE | Daig Corp. | 1989-02-22 | 120 | 0 |
| K884375 | TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER | Argon Medical Corp. | 1989-01-11 | 85 | 0 |
| K882977 | ASK-300 | Medical Repackers Co. | 1989-01-05 | 174 | 0 |
| K881884 | HARBOR CENTRAL VENOUS CATHETER | Harbor Medical Devices, Inc. | 1988-07-28 | 85 | 0 |
| K880771 | MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM | Medsurg Industries, Inc. | 1988-05-03 | 67 | 0 |
| K880776 | 7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM | Medsurg Industries, Inc. | 1988-05-02 | 66 | 0 |
| K873012 | INFANT CANNULA | Gresco International, Inc. | 1988-05-02 | 272 | 0 |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | Bentley Laboratories, Inc. | 1988-01-19 | 71 | 0 |
| K872983 | TORAY ANTHRON ANGIOGRAPHIC CATHETERS | Toray Industries (America), Inc. | 1987-11-20 | 112 | 0 |
| K870826 | ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. | Shiley, Inc. | 1987-03-23 | 20 | 0 |
| K870825 | NEW MODEL STYLES FOR AORTIC ARCH CANNULA | Shiley, Inc. | 1987-03-23 | 20 | 0 |
| K820102 | SUBCLAVIAN JUGULAR CATHETER SET | Luther Medical Products, Inc. | 1982-01-29 | 14 | 0 |
| K813144 | INTRAFLON, INTRAFLUX, INTRAVALVE | Exco, Inc. | 1981-11-27 | 22 | 0 |
| K803002 | ELECATH FLUID-DRAIN ASSEMBLY | Electro-Catheter Corp. | 1980-12-22 | 27 | 0 |
| K780079 | CANNULA, ARTERY, RENAL | Dravon Medical, Inc. | 1978-02-13 | 28 | 0 |
| K770512 | CANNULA, INTRAVENOUS, R | Sherwood Medical Industries | 1977-03-30 | 13 | 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