Atlas FDA

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

Advanced Medical Instruments, Inc. · Predicate Candidate Screening

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

226 daysmedian FDA review time
346 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K923595SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITORAdvanced Medical Instruments, Inc.1993-07-013460
K924910SYSTEM 7500 NIBP/SA02Advanced Medical Instruments, Inc.1993-05-132260
K910521SYSTEM 7300 PULSE OXIMETERAdvanced Medical Instruments, Inc.1991-04-18700
K897173SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITORAdvanced Medical Instruments, Inc.1990-10-233000
K896788DISP. NEONATAL BLOOD PRESSURE MONITORING CUFFAdvanced Medical Instruments, Inc.1990-01-19460

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