Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Devcom, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
16 daysmedian FDA review time
159 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902378 | CARDIOTHORACIC RULER | Devcom, Inc. | 1990-06-14 | 16 | 0 |
| K874233 | BLOOD PRESSURE SLEEVE W/TUBING | Devcom, Inc. | 1988-03-22 | 159 | 0 |
| K863313 | GRIP STRENGTH DEVICE (GSD) | Devcom, Inc. | 1986-09-09 | 14 | 0 |
| K861264 | JOINT MEASUREMENT INDICATOR | Devcom, Inc. | 1986-04-15 | 11 | 0 |
| K861043 | SPINAL EXCURSION METER | Devcom, Inc. | 1986-03-28 | 10 | 0 |
| K850021 | ELECTROCARDIOGRAPH-ECG CALIPER | Devcom, Inc. | 1985-02-08 | 36 | 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