Atlas FDA

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

Kodon(Tianjin)Electronic&Electrical Apparatus Co., · Predicate Candidate Screening

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

174 daysmedian FDA review time
276 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K070828KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORKodon(Tianjin)Electronic&Electrical Apparatus Co.,2007-08-151420
K070826KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITORKodon(Tianjin)Electronic&Electrical Apparatus Co.,2007-08-151420
K070395KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORKodon(Tianjin)Electronic&Electrical Apparatus Co.,2007-06-071180
K052450KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITORKodon(Tianjin)Electronic&Electrical Apparatus Co.,2006-02-281740
K052676KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORKodon(Tianjin)Electronic&Electrical Apparatus Co.,2006-02-171430
K051847KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITORKodon(Tianjin)Electronic&Electrical Apparatus Co.,2006-01-051820
K042418KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORKodon(Tianjin)Electronic&Electrical Apparatus Co.,2005-03-211990
K030359KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONIKodon(Tianjin)Electronic&Electrical Apparatus Co.,2003-11-062760
K030358KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORKodon(Tianjin)Electronic&Electrical Apparatus Co.,2003-10-312700

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