Atlas FDA

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

Midwest Rf, LLC — Predicate Candidate Screening

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

62 daysmedian FDA review time
279 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K111259SV DBS VRAIN ARRAYMidwest Rf, LLC2011-07-05620
K091496MEP-90 HAIR GROWTH STIMULATION SYSTEMMidwest Rf, LLC2010-02-232790
K090267SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64Midwest Rf, LLC2009-03-16410
K051618SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64Midwest Rf, LLC2005-08-02460
K030317MODEL 1300GE-64: PEDIATRIC POSITIONERMidwest Rf, LLC2003-03-25540
K003097BRAIN COIL, MODEL 9800GE-64Midwest Rf, LLC2000-12-28860
K003386SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64Midwest Rf, LLC2000-12-28580
K002860MODEL 6900GE-64: C-SPINE ARRAYMidwest Rf, LLC2000-11-22700
K002864MODEL 6600GE-64: TRAMA NECK ARRAYMidwest Rf, LLC2000-11-21690

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