Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KXM · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925581 | BAXTER BIOSTAT 1000 UREA MONITOR | Baxter Healthcare Corp | 1995-05-03 | 909 | 0 |
| K863471 | COLORADO MEDICAL MODEL PTC 1000 | Colorado Medical, Inc. | 1986-10-02 | 23 | 0 |
| K853536 | VELCRO FISTULA PRESSURE CLAMPS | Cp Medical | 1985-10-17 | 55 | 0 |
| K831402 | PRESSURE MONITOR & CONTROL UNIT APC-02A | Parker Hannifin Corp. | 1983-08-08 | 98 | 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