Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
D.R.O. Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
13 daysmedian FDA review time
52 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K844820 | FLOW MED SK 140 BURET | D.R.O. Medical, Inc. | 1985-01-28 | 52 | 0 |
| K820165 | FLOW MED 311 | D.R.O. Medical, Inc. | 1982-02-01 | 12 | 0 |
| K801821 | FLOW MED 150 | D.R.O. Medical, Inc. | 1980-08-13 | 13 | 0 |
| K801179 | FLOW MED 160 | D.R.O. Medical, Inc. | 1980-05-30 | 14 | 0 |
| K801004 | FLOW MED 160 | D.R.O. Medical, Inc. | 1980-05-02 | 7 | 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