Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Radionics, A Division of Tyco Healthcare Group LP · Predicate Candidate Screening

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

75 daysmedian FDA review time
90 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K051947RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WIRadionics, A Division of Tyco Healthcare Group LP2005-08-22350
K041997RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULERadionics, A Division of Tyco Healthcare Group LP2004-08-27320
K032054RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USERadionics, A Division of Tyco Healthcare Group LP2003-09-15750
K023519RADIONICS VARILINK 2Radionics, A Division of Tyco Healthcare Group LP2003-01-16870
K021942RADIONICS POLE NEEDLESRadionics, A Division of Tyco Healthcare Group LP2002-09-11900
K013661XPLAN 2.2 WITH THE BODY SYSTEMRadionics, A Division of Tyco Healthcare Group LP2001-12-03270
K012850RECORDING AND STIMULATING ELECTRODERadionics, A Division of Tyco Healthcare Group LP2001-11-19870
K010548MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)Radionics, A Division of Tyco Healthcare Group LP2001-03-12140

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