Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bomed Medical Mfr., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
131 daysmedian FDA review time
222 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853706 | BOMED-CDM | Bomed Medical Mfr., Ltd. | 1986-04-14 | 222 | 0 |
| K853705 | BOMED-EEA | Bomed Medical Mfr., Ltd. | 1986-01-13 | 131 | 0 |
| K831421 | BOMED BIOCON | Bomed Medical Mfr., Ltd. | 1983-09-12 | 132 | 0 |
| K831422 | BIOFLOW | Bomed Medical Mfr., Ltd. | 1983-09-12 | 132 | 0 |
| K830792 | PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE | Bomed Medical Mfr., Ltd. | 1983-03-29 | 15 | 0 |
| K813020 | BOMED-NCCOM | Bomed Medical Mfr., Ltd. | 1981-12-14 | 48 | 0 |
| K811999 | BO MED BIA | Bomed Medical Mfr., Ltd. | 1981-08-31 | 51 | 0 |
| K810064 | PULSARII, HIGH VOLT. GALVANIC MUSC. STIM | Bomed Medical Mfr., Ltd. | 1981-01-26 | 13 | 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