Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GXW — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
164 daysmedian FDA review time
249 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921863 | SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS | Hewlett-Packard Co. | 1992-09-28 | 164 | 0 |
| K903085 | SMS-712NA | Toshiba America Medical Systems, In.C | 1990-10-05 | 85 | 0 |
| K853432 | 5.0 IOP & 7.5 IOP PROBES | Diasonics, Inc. | 1986-02-07 | 176 | 0 |
| K833522 | NEURO SECTOR FIXATION DEVICE | Advanced Technology Laboratories, Inc. | 1984-05-25 | 249 | 0 |
| K821736 | ECHO-PULSE KM555 | Rabar, Inc. | 1982-12-09 | 178 | 0 |
| K770788 | ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 | Storz Instrument Co. | 1977-05-06 | 4 | 0 |
| K770575 | ECHOENCEPHALOGRAPH, DIGITAL, 1000 | Storz Instrument Co. | 1977-04-26 | 29 | 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