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

Accucore, Inc. — Predicate Candidate Screening

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

80 daysmedian FDA review time
272 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942147PACIFIC COMMUNICATIONS MODEL 1100Accucore, Inc.1995-01-302720
K925411MODEL 2041-PC/ST CARDIAC TELEMETRY MONITORAccucore, Inc.1993-02-251220
K913576DATASCOPE MODEL VISA CENTRAL MONITORAccucore, Inc.1992-01-281690
K913400MODEL SCR-1000Accucore, Inc.1991-08-21220
K896775PCI MODEL 2041-B TELEMETRY MONITORAccucore, Inc.1990-05-171670
K901031PCI MODEL 2041-PC TELEMETRY MONITORAccucore, Inc.1990-05-17720
K901032PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIAAccucore, Inc.1990-04-04290
K894340PCI MODEL 2041-A TELEMETRY MONITORAccucore, Inc.1989-10-02800
K874387PCI MODEL RS100 TELEMETRY MONITORAccucore, Inc.1987-12-18530

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