Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DXW — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
30 daysmedian FDA review time
337 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972020 | OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR | Cas Medical Systems, Inc. | 1998-05-05 | 337 | 0 |
| K955887 | NEWMED ABP-LITE | Newmed Corp. | 1996-09-05 | 252 | 0 |
| K802830 | MILLAR MIKRO-TIP CATHETER PHONOTRANS | Millar Instruments, Inc. | 1980-12-10 | 30 | 0 |
| K800222 | MODEL 412 ELECTROFLUIDIC MANOMETER | Med-Tek Corp. | 1980-02-29 | 25 | 0 |
| K800179 | INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR | Sphygmetrics, Inc. | 1980-02-11 | 13 | 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