Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Roche Medical Electronics, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
91 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K791559 | ROCHE SENSOR ADAPTOR | Roche Medical Electronics, Inc. | 1979-11-21 | 96 | 0 |
| K791036 | FETASONDE UTERINE WORK MONITOR | Roche Medical Electronics, Inc. | 1979-09-04 | 91 | 0 |
| K791035 | FETASONDE FETAL ACTIVITY MONITOR | Roche Medical Electronics, Inc. | 1979-09-04 | 91 | 0 |
| K791038 | FETASONDE UTERINE ACTIVITY MONITOR | Roche Medical Electronics, Inc. | 1979-09-04 | 91 | 0 |
| K791037 | FETASONDE LABOR STATUS DISPLAY | Roche Medical Electronics, Inc. | 1979-09-04 | 91 | 0 |
| K791039 | FETASONDE FETAL HEART RATE VARIABILITY | Roche Medical Electronics, Inc. | 1979-09-04 | 91 | 0 |
| K790761 | FETASONDE MODEL 2108 | Roche Medical Electronics, Inc. | 1979-06-01 | 45 | 0 |
| K790421 | ROCHE LACTATE ANALYZER 640 | Roche Medical Electronics, Inc. | 1979-05-15 | 76 | 0 |
| K782088 | MONITOR, HEART RATE MODEL 105 | Roche Medical Electronics, Inc. | 1979-01-04 | 21 | 0 |
| K782089 | MONITOR, HEART RATE MODEL 103 | Roche Medical Electronics, Inc. | 1979-01-04 | 21 | 0 |
| K781271 | MONITOR, PO2, INTRAVASCULAR | Roche Medical Electronics, Inc. | 1978-10-12 | 80 | 0 |
| K780179 | LIQUID SCINTILLATION COUNTER | Roche Medical Electronics, Inc. | 1978-02-23 | 20 | 0 |
| K771816 | ROCHE AXISCAN 5 | Roche Medical Electronics, Inc. | 1977-10-19 | 22 | 0 |
| K771478 | INFUSION PUMP #6202 | Roche Medical Electronics, Inc. | 1977-08-22 | 18 | 0 |
| K761057 | ARTERIOSONDE BLOOD PRESS. MNTR. (#1020) | Roche Medical Electronics, Inc. | 1976-12-09 | 21 | 0 |
| K760919 | MODEL 2106 FETA SONDE FETAL MONITOR | Roche Medical Electronics, Inc. | 1976-11-16 | 19 | 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