Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Burditt & Calkins-Siemens-Elema · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
133 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833519 | PULSE GENERATOR MODEL 688 | Burditt & Calkins-Siemens-Elema | 1984-01-30 | 111 | 0 |
| K833155 | RAYDEN MEDICAL MINI PULSE VOLUME RECORD | Burditt & Calkins-Siemens-Elema | 1984-01-26 | 133 | 0 |
| K830344 | SIEMENS-ELMA PULSE GENERATOR #718 | Burditt & Calkins-Siemens-Elema | 1983-05-27 | 114 | 0 |
| K823435 | MON-A-THERM MYOCARDIAL TEMP. SENSOR | Burditt & Calkins-Siemens-Elema | 1982-12-30 | 44 | 0 |
| K823591 | AMEDA HAND BREAST PUMP | Burditt & Calkins-Siemens-Elema | 1982-12-28 | 22 | 0 |
| K822239 | COAXIAL BIPOLAR PACING ELECTRODE | Burditt & Calkins-Siemens-Elema | 1982-10-04 | 68 | 0 |
| K821712 | INFORMED REMOTE FIELD UNIT MODEL IFM1000 | Burditt & Calkins-Siemens-Elema | 1982-07-26 | 47 | 0 |
| K803111 | ERECTAID | Burditt & Calkins-Siemens-Elema | 1981-01-23 | 44 | 0 |
| K802607 | TERPERATUR SENSING DEVICE | Burditt & Calkins-Siemens-Elema | 1980-11-19 | 29 | 0 |
| K760787 | LIBERATOR/STROLLER | Burditt & Calkins-Siemens-Elema | 1976-10-22 | 16 | 0 |
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