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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2745 of 3530

510(k) clearances, page 2745 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880549	Diacyte Fixative Solution	Cytocorp, Inc.	LDY	Class I	1988-04-01
K880544	Wescor Stain Concentrate for Model 7100 Aerospray	ELITechGroup Inc	GJL	Class I	1988-04-01
K880509	Multisurface Roller Bottle (M.s.r.b.)	Motil Plastics, Ltd.	KJC	Class I	1988-04-01
K880470	Bovine Calf Serum Catalog #a-2119	Hyclone Laboratories, Inc.	KIS	Class I	1988-04-01
K880052	Edwards-Duromedics Mitral Valve Rotator	Baxter Healthcare Corporation	DTJ	Class I	1988-04-01
K880021	Cobe Cml3	Cobe Laboratories, Inc.	DTZ	Class II	1988-04-01
K874816	Kontron Intra-Aortic Balloon Pump Model K2000	Kontron Instruments, Inc.	DSP	Class II	1988-04-01
K874725	Site Solution Administration Set	Site Microsurgical Systems, Inc.	FPA	Class II	1988-04-01
K874641	Circadian Stress Test II	Circadian, Inc.	DPS	Class II	1988-04-01
K873972	Guide Wire Introducer	Target Therapeutics	DQX	Class II	1988-04-01
K873965	Frame, Spectacle	Swank Plus, Ltd.	HQZ	Class I	1988-04-01
K872833	Breathguard Apnea Monitor	Lada Intl., Inc.	BZQ	Class II	1988-04-01
K872298	Tegasorb Ulcer Dressing #90-Xxx	3M Company	FRO	Unclassified	1988-04-01
K881130	Cell-Dyn Isotonic Diluent	Abbott Diagnostics	GIF	Class I	1988-03-31
K880894	Allergist Syringes	Abco Dealers, Inc.	FMF	Class II	1988-03-31
K880707	Wheel-Chair W/motor Drive	Paul Weiser Co.	ITI	Class II	1988-03-31
K880691	Earle's Balanced Salts W/out Phenol Red & Sodium	Sigma Chemical Co.	KIT	Class I	1988-03-31
K880632	Proteq Surgeon's Gloves	Strategic Materials Group	KGO	Class I	1988-03-31
K880607	Utility Wax Strips, Spearmint	Columbus Dental Mfg. Co.	EGD	Class I	1988-03-31
K880596	Eosin Y Solution, Alcoholic, with Phloxine	Sigma Chemical Co.	HYB	Class I	1988-03-31
K880578	Lake Disposable Probe Cover	Lake Medical Products, Inc.	FLL	Class II	1988-03-31
K880473	Aero-Mist Nebulizer Heater	Pegasus Research Corp.	CAF	Class II	1988-03-31
K880434	Medicomp Straight Swivel Adaptor	Medicomp, Inc.	BZA	Class I	1988-03-31
K880422	Maestro(r) Model 119, Single-Chamber Pacemaker	Cardiac Control Systems, Inc.	DXY	Class III	1988-03-31
K880393	Transbond Light Cured Orthodontic Adhesive	Unitek Corp.	DYH	Class II	1988-03-31
K880338	Chicopee Adult Incontinence Shields	Chicopee, Inc.	EYQ	Class I	1988-03-31
K880241	'Hilt-Way' Resuscitator	Medifield, Ltd.	CAE	Class I	1988-03-31
K880220	Tri-Stage (Ts-I) Dental Implant	Tri-Stage, Inc.	DZE	Class II	1988-03-31
K880219	Transrectal Probe Bd65s-Tr	Elscint, Inc.	IYO	Class II	1988-03-31
K880134	Middlebrook 7H11 Agar	Hardy Media	KZI	Class I	1988-03-31
K880133	Mil Medium	Hardy Media	JSE	Class I	1988-03-31
K880131	Lowenstein-Jensen, Gruft	Hardy Media	KZI	Class I	1988-03-31
K880126	Lauryl Tryptose Broth	Hardy Media	JSF	Class I	1988-03-31
K880125	Lowenstein-Jensen, Selective	Hardy Media	JSI	Class I	1988-03-31
K880124	Lowenstein-Jensen, W/nacl	Hardy Media	JSJ	Class I	1988-03-31
K880123	Lowenstein-Jensen Slant	Hardy Media	JSJ	Class I	1988-03-31
K880122	Middlebrook 7H9 Broth	Hardy Media	KZI	Class I	1988-03-31
K880121	Moellers Decarboxylase, Base	Hardy Media	JSH	Class I	1988-03-31
K880120	Moellers Decarboxylase, Lysine	Hardy Media	JSF	Class I	1988-03-31
K880119	Moellers Decarboxylase, Onithine	Hardy Media	JSF	Class I	1988-03-31
K880116	Mrvp Broth	Hardy Media	JSE	Class I	1988-03-31
K880079	Takeda Medical Auto. Ambu. Blood Press. Meter/2420	A and D Engineering, Inc.	DSK	Class II	1988-03-31
K875358	Vzv Test	Gull Laboratories, Inc.	GQX	Class II	1988-03-31
K875193	Indistrip (Sterilization Process Indicator)	Indilab, Inc.	JOJ	Class II	1988-03-31
K874726	Mascot Stethoscope Probe	Imex Medical Systems, Inc.	DQD	Class II	1988-03-31
K874668	Sperm Washing Medium #9983 & Modified #9984	Irvine Scientific LLC	HDR	Class II	1988-03-31
K873179	Heater Wire Breathing Circuit	Life Design Systems, Inc.	BZE	Class II	1988-03-31
K872825	Axial Tome, 60, Fluoro and Tomax	Axialtome Corp.	EHD	Class II	1988-03-31
K872024	Co2/02 Monitor Multinex	Datascope Corp.	CCI	Class II	1988-03-31
K881111	Intracellular/extracellular Iron Histology Control	Sigma Diagnostics, Inc.	LJG	Class I	1988-03-30