Atlas FDA

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

Idt Technology Limited — Predicate Candidate Screening

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

153 daysmedian FDA review time
289 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151415Oregon ScientificIdt Technology Limited2015-10-211470
K131245OREGON SCINTIFICIdt Technology Limited2014-01-172610
K050083BLOOD-PRESSURE METER, BPW120Idt Technology Limited2005-04-08850
K031167HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEXIdt Technology Limited2004-01-282890
K020433FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETIdt Technology Limited2002-07-111530
K021252BLOOD-PRESSURE METERIdt Technology Limited2002-06-17590

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