Atlas FDA

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

Spelna, Inc. — Predicate Candidate Screening

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

147 daysmedian FDA review time
220 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K852525SATALEC PIEZOTECSpelna, Inc.1986-01-302300
K852527SATALEC SEPTOSONIC SC 80/SC 120Spelna, Inc.1986-01-032030
K852522SATALEC SERVOTOMESpelna, Inc.1985-12-271960
K8532005X2 SATALEC CHIROPODY CASESpelna, Inc.1985-10-181260
K852521SATLEC PROPHY UNIT PU 3055Spelna, Inc.1985-07-31470
K852524SATALEC SERVOTORQUE S2 SX2Spelna, Inc.1985-07-31470
K832674SATELEC PROPHY UNIT PU 2000SSpelna, Inc.1984-03-162200
K832664SATELEC SUPRASSON PIEZOMATIC P2Spelna, Inc.1984-03-162200
K832665SATELEC SUPRASSON SP 3055Spelna, Inc.1983-10-19710
K832673SATELEC PROPHY UNIT PU-2000Spelna, Inc.1983-10-19710
K820256MEDILAC #SR4 & SR 40Spelna, Inc.1982-06-251470

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