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

NRB — Predicate Candidate Screening

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

69 daysmedian FDA review time

393 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K162721	Stimucel System, Stimucel Generator, Stimucel Treatment Wand	Alliqua Biomedical, Inc.	2016-12-22	84
K140782	ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT W	Celleration, Inc.	2014-08-13	135
K131096	AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM	Arobella Medical, LLC	2014-05-16	393
K123980	SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES	Misonix, Inc.	2013-03-05	69
K122246	MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPL	Celleration, Inc.	2012-08-13	17
K112782	MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSO	Misonix, Inc.	2011-12-01	66
K091038	AS 1000 ULTRASOUND WOUND THERAPY SYSTEM	Arobella Medical, LLC	2009-06-19	67
K050129	CELLERATION MIST THERAPY SYSTEM 5.1	Celleration, Inc.	2005-05-17	118
DEN040004	CELLERATION MIST THERAPY SYSTEM	Celleration	2004-06-25	57

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