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

3M Avi, Inc. — Predicate Candidate Screening

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

41 daysmedian FDA review time
168 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K912069AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET3M Avi, Inc.1993-10-148880
K912589AVI MODEL 840D DUAL CHANNEL INFUSION PUMP3M Avi, Inc.1991-10-171290
K912590AVI MODEL 400D INFUSION PUMP3M Avi, Inc.1991-10-171290
K912591AVI MICRO 210D INFUSION PUMP3M Avi, Inc.1991-09-06880
K912875AVI MODEL 270CI INFUSION PUMP3M Avi, Inc.1991-08-20500
K912738AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS3M Avi, Inc.1991-08-12520
K912031AVI MODEL 870 DUAL CHANNEL INFUSION PUMP3M Avi, Inc.1991-06-18410
K904979AVI MODEL 600 SYRINGE PUMP, MODIFICATION3M Avi, Inc.1991-01-15760
K902858AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET3M Avi, Inc.1990-12-141680
K903787AVI MODEL 470CM INFUSION PUMP3M Avi, Inc.1990-09-05160
K903783AVI MICRO 275CM INFUSION PUMP3M Avi, Inc.1990-09-05160
K903786AVI MICRO 845 DUAL CHANNEL INFUSION PUMP3M Avi, Inc.1990-09-05160
K903785AVI MODEL 400CM INFUSION PUMP3M Avi, Inc.1990-09-05160
K903782AVI MODEL 270CM INFUSION PUMP3M Avi, Inc.1990-09-05160
K903788AVI MICRO 285CM INFUSION PUMP3M Avi, Inc.1990-09-04150
K903784AVI MODEL 480CM INFUSION PUMP3M Avi, Inc.1990-08-30100
K903789AVI MICRO 885 DUAL CHANNEL INFUSION PUMP3M Avi, Inc.1990-08-30100
K903781AVI MODEL 880 DUAL CHANNEL INFUSION PUMP3M Avi, Inc.1990-08-30100

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