Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MVV · Predicate Candidate Screening

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

90 daysmedian FDA review time

243 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K220289	FridaMom Anti-Nausea Bands	Fridababy, LLC	2022-06-29	148	0
K211823	Bonine Acupressure Bands	Wellspring Pharmaceutical Corporation	2021-09-01	79	0
K193374	TumEase Acupressure Bracelets	Mumease	2020-03-04	90	0
K142471	Pressure Right, Single-Use, Disposable, Acupressure, Pressur	Pressure Point, Inc.	2014-12-01	89	0
K110821	BARF BAND	Doodlebug Products, LLC	2012-02-27	340	0
K110563	PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE E	Therapeutics 101, Inc (Dba Pressure Point, Inc.)	2011-04-08	39	0
K070766	PSI BANDS	Psi Health Solutions, Inc.	2007-07-26	128	1
K053509	ACUBAND ACUPRESSURE WRIST BAND DEVICE	Acuband, Inc.	2006-08-16	243	0
K051397	BIOBANDS	Biobands Distributors, Inc.	2005-09-16	112	0
K041766	EZY-TRAVEL WRISTBAND	Apothecary Products, Inc.	2004-11-26	149	0
K041877	ACU-STRAP MOTION SICKNESS BAND	Health Ent., Inc.	2004-10-08	88	0
K033268	SEA-BAND	Sea-Band UK , Ltd.	2004-01-07	90	0
K900588	ACU-BAND ACCUPRESSURE WRIST BAND	Euro-Am Pharma, Inc.	1990-02-22	15	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