Atlas FDA

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

Clinical Connections, Inc. · Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

32 daysmedian FDA review time
89 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K884435RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTSClinical Connections, Inc.1988-11-08260
K871540SWIVEL CONNECTORS #014452/#014453/#014459-120Clinical Connections, Inc.1987-04-30230
K870325#014160-TAB TUBING ROTATOR ADAPTORClinical Connections, Inc.1987-04-27890
K870477DEVICE CONNECTORS #000299-000 3/8 X 3/8 X 3/8 YClinical Connections, Inc.1987-04-03590
K870912T-CONNECTORS 014500/014501/014502/014503-120Clinical Connections, Inc.1987-03-17110
K870913INJECTION SITE #014456-120Clinical Connections, Inc.1987-03-17110
K870324#014460-120 3-WAY & #014461-120 4-WAY STOPCOCKClinical Connections, Inc.1987-03-13440
K870394HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERSClinical Connections, Inc.1987-03-03320
K870073MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TABClinical Connections, Inc.1987-02-20430
K870326VARIOUS LUER AND TUBING FITTINGSClinical Connections, Inc.1987-02-10130

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