Atlas FDA

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

Michigan Instruments, Inc. — Predicate Candidate Screening

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

55 daysmedian FDA review time
106 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K073079THUMPER, MODEL: 1008Michigan Instruments, Inc.2008-02-141060
K972525THUMPERMichigan Instruments, Inc.1997-10-02872
K962237THUMPER CARDIOPULMONARY RESUSCITATORMichigan Instruments, Inc.1996-09-05860
K895954LARYNGOSTAT LARYNGOSCOPE HANDLEMichigan Instruments, Inc.1989-10-30190
K851139THUMPER CARDIOPULMONARY RESUSCITATOR 1005Michigan Instruments, Inc.1985-05-15550
K833879CARDIOPULMONARY RESUSCITATORMichigan Instruments, Inc.1983-12-27490
K811909CARDIOPULMUNARY RESUSCITATORMichigan Instruments, Inc.1981-07-16150

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