Atlas FDA

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

Suntech Medical, Inc. · Predicate Candidate Screening

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

72 daysmedian FDA review time
259 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151520Oscar 2Suntech Medical, Inc.2016-02-192590
K122401TANGO M2 BLOOD PRESSURE MONITORSuntech Medical, Inc.2012-11-02870
K080854DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100Suntech Medical, Inc.2008-10-202070
K070750247 BP DEVICESuntech Medical, Inc.2007-05-02440
K060820CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060Suntech Medical, Inc.2006-06-07720
K053209TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASURSuntech Medical, Inc.2006-01-05500
K051904ALL PURPOSE CUFF, MODEL 222APCSuntech Medical, Inc.2005-09-09580

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