Atlas FDA

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

Radkor, Inc. — Predicate Candidate Screening

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

36 daysmedian FDA review time
142 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K895969RADKOR DXG-650RRadkor, Inc.1989-11-13320
K892196RADKOR TS10-BRadkor, Inc.1989-04-26230
K891395RADKOR BS-10 AND BS-10TRadkor, Inc.1989-04-03200
K883885RADKOR, RF-159Radkor, Inc.1988-10-19360
K883864RADKOR SFR-70Radkor, Inc.1988-10-19360
K881701RADKOR SFC-21Radkor, Inc.1988-09-081420
K881696RADKOR XG-325Radkor, Inc.1988-09-021360
K883081RADKOR, XG-515Radkor, Inc.1988-09-02430
K881700RADKOR KOB-84Radkor, Inc.1988-09-021360
K882563RADKOR, CST-18Radkor, Inc.1988-07-08170

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