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

Solco Basle, Inc. — Predicate Candidate Screening

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

121 daysmedian FDA review time
589 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K913247SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEMSolco Basle, Inc.1993-02-255840
K913177SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEMSolco Basle, Inc.1993-02-255890
K915867SOLCOVAC WOUND DRAINAGE SYSTEMSolco Basle, Inc.1992-08-142270
K896858SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEMSolco Basle, Inc.1990-04-051210
K896857SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEMSolco Basle, Inc.1990-04-051210
K896203SOLCOSEPT(TM) BLOOD TRANSFUSION FILTERSolco Basle, Inc.1990-02-01980
K883058SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEMSolco Basle, Inc.1988-10-281010
K872590SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEMSolco Basle, Inc.1987-09-04650
K872157HALL VEIN STRIPPERSolco Basle, Inc.1987-07-07330
K843821SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUSSolco Basle, Inc.1985-10-013680

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