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

JOT · Predicate Candidate Screening

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

101 daysmedian FDA review time

137 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K923647	RFG-DGP DISPOSABLE GROUNDING PADS	Radionics, Inc.	1992-11-09	111
K905545	ULTRASOUND TRANSMISSION GEL	Arbo Medical, Inc.	1991-03-29	108
K904418	ULTRASOUND COUPLING GEL	Geno Laboratories	1991-02-11	137
K901217	TRIA-SONIC ULTRA SOUND TRANSMISSION GEL	H & P Industries, Inc.	1990-06-22	101
K894490	STERILE ULTRASOUND TRANSMISSION GEL	Swedish Trade Council USA	1989-10-05	79
K884503	ULTRASONIC TRANSMISSION GEL	Herbert Stanley Co.	1989-02-13	111
K872519	STERILIZED OMNI GEL	Echo Ultrasound	1987-08-03	39
K871565	ULTRASOUND TRANSDUCER GEL, STERILE	Amedic USA	1987-07-15	84
K800933	R2 ELECTROSURG. RETURN ELECT. #225ETC.	R2 Corp.	1980-05-20	29

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