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

BXQ — Predicate Candidate Screening

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

98 daysmedian FDA review time

469 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K221892	VISIONAIR	Pacificmd Biotech, LLC	2022-10-05	98
K170071	SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer,	Sleep Group Solutions	2017-11-09	304
K022311	RHINOSTREAM RHINOMANOMETER MODULE	Rhino Metrics A/S	2002-10-04	79
K011329	ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETE	E. Benson Hood Lab, Inc.	2002-07-26	451
K000406	RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MO	Rhino Metrics A/S	2000-04-17	70
K972140	A1 ACOUSTIC RHINOMETER	G.M. Instruments , Ltd.	1998-09-30	481
K921452	ACOUSTIC RHINOMETER	Hood Laboratories	1993-07-08	469
K902120	MERCURY RHINOMANOMETER	Life-Tech Intl., Inc.	1990-08-06	87
K896263	RHINOMANOMETER	Jedmed Instrument Co.	1990-04-16	167
K853024	RHINOTEST MP	Intertronic, Inc.	1985-09-27	71
K851143	RHINOMANOMETERS NR3, NR4	And/Or Corp.	1985-05-23	63
K844230	RHINOMANOMETER A440 DIGITAL	Center Laboratories, Inc.	1984-11-27	26

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