Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Compumed, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
169 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984285 | OSTEOGRAM BONE DENSITOMETER | Compumed, Inc. | 1999-05-19 | 169 | 0 |
| K955708 | COMPUMED DICON CLIENT | Compumed, Inc. | 1996-03-01 | 78 | 0 |
| K863965 | KENZ-ECG 102 | Compumed, Inc. | 1986-12-22 | 73 | 0 |
| K854626 | COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B | Compumed, Inc. | 1986-02-28 | 102 | 0 |
| K802272 | COMPUTER ECG TERMINAL | Compumed, Inc. | 1980-09-26 | 9 | 0 |
| K771648 | COMPUTER ECG TERMINAL | Compumed, Inc. | 1977-09-20 | 22 | 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