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

Avi, Inc. — Predicate Candidate Screening

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

87 daysmedian FDA review time
175 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K882047ENTRUST(TM) MODEL 800Avi, Inc.1988-08-11870
K875348MODEL 400A INFUSION PUMPAvi, Inc.1988-04-291200
K875347MODEL 210A INFUSION PUMPAvi, Inc.1988-04-291200
K875365MODEL 200A INFUSION PUMPAvi, Inc.1988-04-291200
K872516INFUSION PUMP MODEL 275Avi, Inc.1987-12-161750
K872514INFUSION PUMP MODEL 270Avi, Inc.1987-12-161750
K872515INFUSION PUMP MODEL 470Avi, Inc.1987-12-161750
K854073MODEL 210 INFUSION PUMPAvi, Inc.1985-12-10670
K854074MODEL 200 INFUSION PUMPAvi, Inc.1985-12-10670
K843616AVI GUARDIAN 400 INFUSION PUMPAvi, Inc.1984-10-31470
K843615AVI GUARDIAN MICRO 410 INFUSION PUMPAvi, Inc.1984-10-31470
K823406GUARDIAN 110, VOL. CONTROL DELIV. SYSAvi, Inc.1982-12-22370
K811933GUARDIAN, VOLUMETRIC CONTROL DELIVERYAvi, Inc.1981-07-201432

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