Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

PFW — Predicate Candidate Screening

9 FDA 510(k) clearances under this product code; the 50 most recent screened below.

210 daysmedian FDA review time
267 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLC2026-04-281060
K233210sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLC2023-10-25270
K223019sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC2023-06-232670
K221210PainShield MD PLUSNanovibronix, Inc.2022-11-232100
K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC2021-08-18960
K191568sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC2020-03-062670
K130978ZTX ULTRASONIC DIATHERMY DEVICEZetroz, Inc.2013-11-062110
K081075PAINSHIELD MDNano Vibronix , Ltd.2008-08-221280
K072256HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED Hill Laboratories Co.2008-03-122120

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