Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

OTJ — Predicate Candidate Screening

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

156 daysmedian FDA review time
261 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232062Uni-portDalim Medical Corp.2024-01-161890
K220081CORE-SPORTIncore Co., Ltd.2022-09-282610
K202688AFS Medical Sterile Single-Use Access Port SystemAfs Medical Co. , Ltd.2021-10-143940
K160797FMX314 Surgical PlatformFortimedix Surgical B.V.2016-08-261560
K152598Endo KeeperNelis2016-03-171880
K121309ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts2012-09-061280
K120898KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 88Richard Wolf Medical Instruments Corp.2012-08-031300
K111407TRIPORT, TRIPORT+, TRIPORT15, QUADPORTAdvanced Surgical Concepts2012-01-182440
K112196OCTOTMPORTDalim Surgnet Corporation2011-09-14440
K110004ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts2011-01-26230
K101794ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA5Advanced Surgical Concepts2010-11-291540

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