Atlas FDA

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

Acumed Instruments Corp. — Predicate Candidate Screening

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

31 daysmedian FDA review time
87 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K863627MICRO SURGICAL DRILL SYSTEMAcumed Instruments Corp.1986-10-02150
K853659POWERED IRRIGATION FOR MICRO SURGICAL DRILLAcumed Instruments Corp.1985-09-24210
K853658BURS FOR MICRO SURGICAL DRILL SYSTEMAcumed Instruments Corp.1985-09-24210
K853660MICRO SURGICAL DRILL SYSTEMAcumed Instruments Corp.1985-09-24210
K791891ACU-MED RED MISER HEMOTHORAX BLOOD COLL.Acumed Instruments Corp.1979-12-05710
K791399ACU-ALERTAcumed Instruments Corp.1979-10-11870
K791400GASTRIC LAVAGE KIT-DISPOSABLEAcumed Instruments Corp.1979-08-16310
K790901I.V. TUBING ORGANIZERAcumed Instruments Corp.1979-06-27480

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