Atlas FDA

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

Solarcare, Inc. — Predicate Candidate Screening

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

154 daysmedian FDA review time
647 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K934775STC COCAINE METABOLITE EIASolarcare, Inc.1995-07-146470
K944372STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIASolarcare, Inc.1995-02-081540
K941496SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAYSolarcare, Inc.1994-10-272130
K941497SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAYSolarcare, Inc.1994-05-24570
K934376STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIASolarcare, Inc.1993-12-07890
K933327HISTOFREEZERSolarcare, Inc.1993-10-291130

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