Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BZN — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
102 daysmedian FDA review time
206 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924373 | ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP | Instrumed, Inc. | 1992-11-25 | 89 | 0 |
| K872558 | CART, EMERGENCY, CARDIOPULMONARY | Nico Metal Products Corp. | 1987-07-24 | 25 | 0 |
| K850761 | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C | Medicor USA , Ltd. | 1985-09-19 | 206 | 0 |
| K840264 | SERVO CART 170 | Siemens Elema AB | 1984-02-04 | 12 | 0 |
| K832697 | RMP INTUBATION EQUIP. STORAGE TRAY | Rmp Co. | 1983-12-27 | 139 | 0 |
| K832356 | PORTABLE OPERAT. RM. MONITORS HS30/40 | Medtel Pty. , Ltd. | 1983-10-28 | 102 | 0 |
| K832355 | CRASH CART | Quinton, Inc. | 1983-10-28 | 102 | 0 |
| K772320 | EMERGENCY CART | Physio-Control Corp. | 1978-01-03 | 15 | 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