Atlas FDA

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

Solaris Medical Technology, Inc. · Predicate Candidate Screening

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

208 daysmedian FDA review time
268 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K100077NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL TSolaris Medical Technology, Inc.2010-10-072680
K101972SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFSSolaris Medical Technology, Inc.2010-07-2290
K092950SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SESolaris Medical Technology, Inc.2010-03-121690
K073249SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACSolaris Medical Technology, Inc.2008-07-252490
K061931SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELSolaris Medical Technology, Inc.2007-01-312080

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