Atlas FDA

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

Amici, Inc. — Predicate Candidate Screening

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

152 daysmedian FDA review time
632 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K063716AEROSOL SYSTEMAmici, Inc.2007-12-283790
K952910THE SWIRLER NEBULIZERAmici, Inc.1997-03-196320
K952893THE SWIRLER AEROSOL SYSTEMAmici, Inc.1995-11-031330
K904684AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATIONAmici, Inc.1991-01-141520
K903805AMICI XENON ADMINISTRATION SETAmici, Inc.1991-01-141520
K903694AMICI TRU-FIT SOFT PLASTIC MOUTHPIECEAmici, Inc.1990-10-03490
K872920AMICI KRYPTON ADMINISTRATION SYSTEM*Amici, Inc.1988-02-122000
K865084AMICI XENON REBREATHING SYSTEM*Amici, Inc.1987-03-03630

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