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

Allen Medical Systems, Inc. — Predicate Candidate Screening

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

70 daysmedian FDA review time
407 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K971988ALLEN, ULTRA AND SMART SOCKETSAllen Medical Systems, Inc.1997-07-11430
K964273DURA-BOARD ARMBOARDAllen Medical Systems, Inc.1997-01-08720
K960027HIGH VOLUME I.V. & IRRIGATION TOWERAllen Medical Systems, Inc.1996-03-12700
K944779CARBON LIGHTS HAND SURGERY TABLEAllen Medical Systems, Inc.1994-10-14170
K921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000Allen Medical Systems, Inc.1993-04-214070

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