Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BXW — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
80 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853848 | RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR | Medical Graphics Corp. | 1985-12-05 | 80 | 0 |
| K831758 | FLOW-CALIBRATION MODULE | The Perkin-Elmer Corp. | 1983-07-19 | 48 | 0 |
| K830898 | SYRINGE 500BC BE #7000 | Instrumentation Industries, Inc. | 1983-05-16 | 56 | 0 |
| K812765 | DATASCRIBE #DS-40 | Timeter Instrument Corp. | 1981-11-16 | 42 | 0 |
| K810290 | OHIO CAL-CHEK | Ohio Medical Products | 1981-02-12 | 9 | 0 |
| K760520 | CALIPERS, MCGAW SKINFOLD | Mcgaw Laboratories | 1976-11-12 | 78 | 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