Atlas FDA

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

Solcoor, Inc. — Predicate Candidate Screening

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

214 daysmedian FDA review time
495 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K882386AGAR 3K NEUROMUSCULAR STIMULATORSolcoor, Inc.1989-10-184950
K882387AGAR 4000 NEUROMUSCULAR STIMULATORSolcoor, Inc.1989-10-164930
K862454AGAR 7K TENS INSTRUMENTSolcoor, Inc.1987-03-252710
K861894AGAR 9K TENSSolcoor, Inc.1986-09-091160
K861895UNI-TENSSolcoor, Inc.1986-09-091160
K861896UNI-TENS XL TENSSolcoor, Inc.1986-09-091160
K851265PEAK FLOWMETERS FOR SPIROMETRYSolcoor, Inc.1985-10-292140

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