Atlas FDA

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

Siemens Medical Electronics · Predicate Candidate Screening

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

147 daysmedian FDA review time
392 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K935043SIEMENS CLINICAL WORK STATIONSiemens Medical Electronics1995-04-075330
K921930SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFISiemens Medical Electronics1993-05-073780
K920445SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIESSiemens Medical Electronics1993-03-023920
K914765SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYSSiemens Medical Electronics1992-11-063810
K912070SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNITSiemens Medical Electronics1992-04-233490
K913489SIEMENS MICRO2 PULSE OXIMETERSiemens Medical Electronics1991-10-30850
K905775SIEMENS ETCO2 CARTRIDGESiemens Medical Electronics1991-03-11740
K900319SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEMSiemens Medical Electronics1990-06-281560
K901771SIEMENS SIRECUST 732, PATIENT MONITORSiemens Medical Electronics1990-05-30410
K894460SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIASiemens Medical Electronics1989-10-02760
K891481SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDESiemens Medical Electronics1989-09-291960
K893470SIEMENS SAO2 + PULS OXIMETRY CARTRIDGESiemens Medical Electronics1989-08-03910
K891023SIEMENS CEILING STAND 800F, 800 AND 810Siemens Medical Electronics1989-07-251470
K890791SIEMENS SIRECUST 730 PATIENT MONITORSiemens Medical Electronics1989-05-02740
K881939SIRECUST 1280/1281 & 960/961 PATIENT MONITORSSiemens Medical Electronics1988-07-18700

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