Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Siemens Ultrasound, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
204 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912361 | SI-450/ILUS (INTRALUMINAL ULTRASOUND) | Siemens Ultrasound, Inc. | 1991-12-02 | 187 | 0 |
| K914013 | SIEMENS SI-400 | Siemens Ultrasound, Inc. | 1991-12-02 | 84 | 0 |
| K911200 | SI-1200 / ILUS | Siemens Ultrasound, Inc. | 1991-06-17 | 90 | 0 |
| K904017 | SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES | Siemens Ultrasound, Inc. | 1991-03-21 | 203 | 0 |
| K910669 | 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU | Siemens Ultrasound, Inc. | 1991-03-15 | 28 | 0 |
| K910529 | 7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS | Siemens Ultrasound, Inc. | 1991-03-15 | 35 | 0 |
| K891449 | SONOLINE CF | Siemens Ultrasound, Inc. | 1989-10-05 | 204 | 0 |
| K891238 | SIEMENS TRANSESOPHAGEAL ECHO TEE TRANSDUCER | Siemens Ultrasound, Inc. | 1989-06-05 | 90 | 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