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

Invivo Research, Inc. — Predicate Candidate Screening

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

251 daysmedian FDA review time
534 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K050399MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160Invivo Research, Inc.2005-08-261910
K043354MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701Invivo Research, Inc.2005-01-10350
K041918INTEGRATED PATIENT MONITORING SYSTEMInvivo Research, Inc.2004-10-15910
K040915MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150MInvivo Research, Inc.2004-09-221670
K002604CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORINGInvivo Research, Inc.2002-02-075340
K002030OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MInvivo Research, Inc.2000-09-26850
K980045CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTInvivo Research, Inc.1998-11-163140
K974581MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENTInvivo Research, Inc.1998-10-283240
K971840OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEMInvivo Research, Inc.1998-03-042890
K955045OMNI-TRAK PATIENT MONITORING SYSTEMInvivo Research, Inc.1996-07-112510
K945138OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORSInvivo Research, Inc.1995-11-203960
K935020OMNI-TRAC MODIFICATIONInvivo Research, Inc.1995-04-265530
K936051OMNI-CENTRAL STATION MONITORInvivo Research, Inc.1994-07-061980
K890817OMNI-TRAK (PATIENT MONITOR)Invivo Research, Inc.1989-08-101740

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