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

Burke Neutech, Inc. · Predicate Candidate Screening

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

164 daysmedian FDA review time
323 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K955326SPORTS CONTRAST THERAPY SYSTEM ST 7000Burke Neutech, Inc.1996-04-101420
K952117EPILATORBurke Neutech, Inc.1995-10-191670
K943497CONTRAST 7000 THERAPY SYSTEMBurke Neutech, Inc.1995-06-073230
K945803THERMAFLEX, MODEL SD 55 C.P.M.H.Burke Neutech, Inc.1995-05-111640
K942926NEURO-AIDEBurke Neutech, Inc.1994-08-03420
K940160TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEMBurke Neutech, Inc.1994-05-271350
K926151LSI6000 THERMAL THERAPY SYSTEMBurke Neutech, Inc.1993-05-261700

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