Atlas FDA

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

Elema-Schonander, Inc. — Predicate Candidate Screening

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

52 daysmedian FDA review time
82 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K934944MPQ-42Elema-Schonander, Inc.1993-12-15580
K904103SEP 90Elema-Schonander, Inc.1990-11-20750
K903576PUCK 90MElema-Schonander, Inc.1990-09-04270
K842911PUCK U & UD CUTFILM CHANGERSElema-Schonander, Inc.1984-08-21290
K842903SEP PROGRAMMER FOR PUCK U & UD FILMCHANGElema-Schonander, Inc.1984-08-21280
K840389SEP PROGRAMMER SEP-M/SINGLE-PLANE &Elema-Schonander, Inc.1984-02-21220
K790792PULSE GENERATOR MODEL 637Elema-Schonander, Inc.1979-10-121710
K790670PULSE GENERATOR MODEL 629Elema-Schonander, Inc.1979-06-27820
K781178PULSE GENERATOR MODEL 208Elema-Schonander, Inc.1978-09-07590
K770005PACEMAKER 208SElema-Schonander, Inc.1977-02-24520
K770135LEAD MODIFICATIONElema-Schonander, Inc.1977-02-07140

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