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

Churchill Medical Systems, Inc. — Predicate Candidate Screening

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

69 daysmedian FDA review time
117 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K041038CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINERChurchill Medical Systems, Inc.2004-12-212430
K021395MODIFICATION TO 30 EXTENSION SETChurchill Medical Systems, Inc.2002-05-131116
K013949UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTORChurchill Medical Systems, Inc.2002-03-271170
K020544WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUChurchill Medical Systems, Inc.2002-03-12251
K013950VENTED VIAL ACCESS DEVICEChurchill Medical Systems, Inc.2002-01-10410
K012157CHURCHILL MEDICAL SYSTEMS STOPCOCKChurchill Medical Systems, Inc.2001-09-11620
K011888PRESSURE ACTIVATED CHECK VALVEChurchill Medical Systems, Inc.2001-09-10840
K011336PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE ANChurchill Medical Systems, Inc.2001-06-12419
K896333CMS IV FILTERSChurchill Medical Systems, Inc.1990-01-11690
K894954.22 & 1.2 MICRON IV FILTERSChurchill Medical Systems, Inc.1989-11-131010
K884370CMS IV EXTENSION SETSChurchill Medical Systems, Inc.1988-11-07200
K88250330 IV EXTENSION SET W/TWO MALE LUER LOCKSChurchill Medical Systems, Inc.1988-08-25690

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