Atlas FDA

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

Integrated Display Technology, Ltd. · Predicate Candidate Screening

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

180 daysmedian FDA review time
246 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K951977DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883Integrated Display Technology, Ltd.1995-10-241800
K941490BLOOD PRESSURE METER MODEL NO. BPM888Integrated Display Technology, Ltd.1994-11-292460
K942336AUTOMATIC DIGITAL BLOOD PRESSURE MONITORIntegrated Display Technology, Ltd.1994-11-281960
K894627BT-338N ELECTRONIC CLINICAL THERMOMETERIntegrated Display Technology, Ltd.1989-10-23910
K853130INTEGRATED DISPLAY TECHNOLOGY LTD.Integrated Display Technology, Ltd.1985-11-081050

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