Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biostim, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
109 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K844023 | AQUAFORM ELECTRODES WITH AQUAPORE | Biostim, Inc. | 1985-02-01 | 109 | 0 |
| K840725 | CLINICAL CARE STIMULATOR | Biostim, Inc. | 1984-04-18 | 57 | 0 |
| K840724 | MUSCLE STIMULATOR X-10 | Biostim, Inc. | 1984-03-05 | 13 | 0 |
| K820678 | SYSTEM 10 | Biostim, Inc. | 1982-03-23 | 12 | 0 |
| K802227 | ANASTIM II TRANSCUTANEOUS ELECTRICAL | Biostim, Inc. | 1980-09-26 | 14 | 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