510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,569

176,366 records, page 3338 of 3528

510(k) clearances, page 3338 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K801752	Rami Tan Ultraviolet B Booth	Rami-Tan	LEJ	Class II	1980-09-16
K801751	Rami Ultraviolet a Booth	Rami-Tan	LEJ	Class II	1980-09-16
K801750	Beckman Astra Systems Albumin Chemistry	Beckman Instruments, Inc.	CIX	Class II	1980-09-16
K801749	Beckman Astra Systems Total Protein Chem	Beckman Instruments, Inc.	CEK	Class II	1980-09-16
K801735	Aria II 125- I-Estriol System	BD Becton Dickinson Vacutainer Systems Preanalytic	CGI	Class I	1980-09-16
K801733	Fenzl Reticle	Robert E. Fenzl, M.D.	HOI	Class I	1980-09-16
K801722	Cmv Bio-Bead Titration Kit	Litton Bionetics	GQH	Class II	1980-09-16
K801721	Hsv Bio-Bead Titration Kit	Litton Bionetics	GQN	Class II	1980-09-16
K801720	Toxo Bio-Bead Titration Kit	Litton Bionetics	GLZ	Class II	1980-09-16
K801689	Sonatron Ultrasonic Dental Scanner	Simplified Systems, Inc.	ELC	Class II	1980-09-16
K801674	Sun Room Tanning Booth	Sun Tan Enterprises, Inc.	LEJ	Class II	1980-09-16
K801669	J.t. Baker Alpha-1-Antitrypsin Nephelo	J.T. Baker Chemical Co.	DEM	Class II	1980-09-16
K801662	J.t. Baker Alpha-2-Macroglobulin Neph.	J.T. Baker Chemical Co.	DEP	Class II	1980-09-16
K801661	J.t. Baker Ceruloplasmin Nephelometric	J.T. Baker Chemical Co.	DDB	Class II	1980-09-16
K801596	Cynergy Model 184	Cynergy	DTE	Class II	1980-09-16
K801588	Caulk Prisma-Lite	Dentsply Intl.	EBZ	Class II	1980-09-16
K801543	Sun Valley Tans	Sun Valley Tans, Inc.	LEJ	Class II	1980-09-16
K801536	Blood Glucose Tester	Broomer Research Corp.	JJQ	Class I	1980-09-16
K801508	Siemens-Elema Pulse Generator 625	Siemens Elema AB	DXY	Class III	1980-09-16
K801454	Datason Rtl	General Electric Co.	IYO	Class II	1980-09-16
K801098	Enzyme-Immunoassay (Rubella Antibodies)	Flow Laboratories, Inc.	GOL	Class II	1980-09-16
K802224	Quintrex 0516 Prog. Pulse Generator Sys	Medcor, Inc.			1980-09-12
K802223	Quintrex 0515 Programmable Pulse Gen.	Medcor, Inc.			1980-09-12
K802187	Sterile Disposable Cytology Brush	Olympus Corp.			1980-09-10
K802070	Vital Signs PEEP Valve	Vital Signs, Inc.	BYE	Class II	1980-09-09
K802069	Disp. Transducer Domes Td200 & Td300	Bio-Med Corp.	DRS	Class II	1980-09-09
K802065	Continuous Epidural Anesthesia Tray/drug	Abbott Medical	BSO	Class II	1980-09-09
K802062	Sof-Touch Nasal Cannula Cat.#304 & 305	Hospitak, Inc.	CAT	Class I	1980-09-09
K802044	Ampco Skin Scrub Trays, Cat.#ss612	Associated Medical Products Co.	LDQ		1980-09-09
K802040	Battery for #229-01 Pulse Generator	Intermedics, Inc.	DXY	Class III	1980-09-09
K802023	Culswab Cat.#978 & 979	Pollak (Intl.).ltd	JTW	Class I	1980-09-09
K802020	Prep Set Cat.#908	Pollak (Intl.).ltd	KXF	Class I	1980-09-09
K802015	Finger Painguard Cat.#193-194	Pollak (Intl.).ltd	FQM	Class I	1980-09-09
K802012	Tribag, Urine Bag System #1109,& 1301-12	Pollak (Intl.).ltd	KNX	Class II	1980-09-09
K802008	Breaking Cast Wire Cat.#1112-1115	Pollak (Intl.).ltd			1980-09-09
K802003	Plastic Disposable Razor Cat.#1017,1018	Pollak (Intl.).ltd	LDQ		1980-09-09
K802002	Urine Specimen Container #'S 1013-1016	Pollak (Intl.).ltd	FMH	Class I	1980-09-09
K801998	Sterile Examination Glove #5121-5126	Pollak (Intl.).ltd	FMC	Class I	1980-09-09
K801997	Embossed Disp. Poly. Gloves #5101-03	Pollak (Intl.).ltd	FMC	Class I	1980-09-09
K801995	Eye Pads Cat.#581-599	Pollak (Intl.).ltd	HMP	Class I	1980-09-09
K801990	Elastic Bandage Cat.#182-186 (Width)	Pollak (Intl.).ltd	FQM	Class I	1980-09-09
K801985	Bio-Med Corp. Disp. Non-Sterile Transdu	Bio-Med Corp.	DRS	Class II	1980-09-09
K801984	Fe-3000 Fetal Electrode, Spiral System	Life Support, Inc.	HGP	Class II	1980-09-09
K801980	Spor-Test Culture Media	Mdt Corp., Inc.	JSG	Class I	1980-09-09
K801975	Little Giant I & II Handpiece Control	Silverman'S	EIA	Class I	1980-09-09
K801958	Rionet Hearing Aid Hb-70H	Rion Acoustic Instruments, Inc.	ESD	Class I	1980-09-09
K801943	Brain Heart Infusion Microbiological	Radiation Technology, Inc.	JSG	Class I	1980-09-09
K801938	Rhinometer	Aztec Medical Products, Inc.	JYJ	Class I	1980-09-09
K801932	Hep-Trol	Helena Laboratories, Corp.	GGW	Class II	1980-09-09
K801930	Ivac 811Y Elec. Clinical Thermometer	Y	FLL	Class II	1980-09-09