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 2026-10-15, 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 3215 of 3528

510(k) clearances, page 3215 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821955	Mcsck638 Catheter in a Tray (Kit)	Medcomp	LFJ	Class II	1982-07-14
K821954	Mcsck838 Catheter in a Tray (Kit)	Medcomp	LFJ	Class II	1982-07-14
K821909	Littman Tunable Stethoscope 2136	3M Company	LDE	Class I	1982-07-14
K821900	Hearing Aid, Unitron Model Ue5	Unitron Industries, Inc.	ESD	Class I	1982-07-14
K821899	Hearing Aid, Unitron Models Ue3/3-N	Unitron Industries, Inc.	ESD	Class I	1982-07-14
K821883	Ultrazyme Plus Ck-I	Harleco Diagnostics	CGS	Class II	1982-07-14
K821882	Ultrazyme Plus Gpt	Harleco Diagnostics	CKA	Class I	1982-07-14
K821881	Ultrachem Crea	Harleco Diagnostics	CGX	Class II	1982-07-14
K821880	Ultra Chem Alb	Harleco Diagnostics	CIX	Class II	1982-07-14
K821879	Ultrachem T.p.	Harleco Diagnostics	CEX	Class II	1982-07-14
K821878	Ultrazyme Plus Ldh	Harleco Diagnostics	CFJ	Class II	1982-07-14
K821877	Ultrazyme Plus Hbd	Harleco Diagnostics	JMK	Class I	1982-07-14
K821873	Ultrachem T-Bili	Harleco Diagnostics	CIG	Class II	1982-07-14
K821872	Ultrachem Uric Acid Aidh	Harleco Diagnostics	CDO	Class I	1982-07-14
K821871	Ultrazyme Plus 2Gt	Harleco Diagnostics	JPZ	Class I	1982-07-14
K821865	A O Microscope Video System	Warner-Lambert Co.	IBJ	Class I	1982-07-14
K821696	The Soft Pedal	Habco Products, Inc.	JOW	Class II	1982-07-14
K821614	As20 Monitoring System	Narco Scientific	DXN	Class II	1982-07-14
K821612	Model 16800 Trend Recorder	Healthdyne, Inc.	DSF	Class I	1982-07-14
K821497	Disposable Surgical Scrub Brushes	Medical Systems Research	GEC	Class I	1982-07-14
K821356	Deseret Capacity Plus Electrosurg. Pad	Warner-Lambert Co.	GEI	Class II	1982-07-14
K821324	Argyle Intramedicut Catheter Kit	Sherwood Medical Co.	DYB	Class II	1982-07-14
K821209	Sgot Reagent Set	Omega Medical Electronics	CIQ	Class II	1982-07-14
K821207	Sgpt Reagent Set	Omega Medical Electronics	CKD	Class I	1982-07-14
K821170	Cornea Perservation Unit	Xytex Corp.	LYX	Unclassified	1982-07-14
K820643	Ortho Spectrum III & Ortho-Mune Ok	Ortho Diagnostic Systems, Inc.	LIZ	Class II	1982-07-14
K827377	Model Ls 3000 Linear Scanner	Hitachi Medical Corp.			1982-07-13
K821939	Urocomp Model 1404	Life-Tech Intl., Inc.	FAP	Class II	1982-07-13
K821924	Table, Operating, Field 6530-00-709-8155	Emerson-Sack-Warner Corp.	FSE	Class I	1982-07-13
K821923	Table, Operating, Field 6530-00-709-8175	Emerson-Sack-Warner Corp.	FWX	Class I	1982-07-13
K821906	Corpak Enteric Feeding Tube W/guide Tip	Halyard Health	KNT	Class II	1982-07-13
K821892	Phillips Radiation Measuring Instrument	Long Island Scientific	JJJ	Class I	1982-07-13
K821885	Ref. Electrode Sol'n.;standard B	Avl Scientific Corp.	JIX	Class II	1982-07-13
K821876	Ultrazyme Plus Got	Harleco Diagnostics	CIT	Class II	1982-07-13
K821875	Ultrachem Tri-Es	Harleco Diagnostics	CDT	Class I	1982-07-13
K821874	Ultrachem Phos	Harleco Diagnostics	CEO	Class I	1982-07-13
K821870	Ultrazyme Plus Alp	Harleco Diagnostics	CJE	Class II	1982-07-13
K821869	Ultrazyme Plus Amyl	Harleco Diagnostics	JFJ	Class II	1982-07-13
K821864	Thioglycollate Med. W/vitamin K-1	Granite Diagnostics, Inc.	JSC	Class I	1982-07-13
K821831	A O Histostat Embedding Ctr #8030,32,34	Warner-Lambert Co.	IDS	Class I	1982-07-13
K821820	Mcsc6ps Medical Components	Medical Components, Inc.	LFL	Unclassified	1982-07-13
K821798	82 Alloy	J. Aderer, Inc.	EJS	Class II	1982-07-13
K821731	Healthdyne Model 16900 Infant Monitor	Healthdyne, Inc.	BZQ	Class II	1982-07-13
K821721	Clinical Data Apnea Detector	Clinical Data, Inc.	FLS	Class II	1982-07-13
K821692	Passive Heat Pads	Biotone International, Inc.	IRT	Class II	1982-07-13
K821664	Pp-100, Personal Perineometer	Farrall Instruments, Inc.	HIR	Class II	1982-07-13
K821657	Riagen B-Hcg Ria	Biogenex Laboratories, Inc.	JHI	Class II	1982-07-13
K821560	Level II Lipid Control	Irvine Scientific LLC	JJY	Class I	1982-07-13
K821559	Level I Lipid Control	Irvine Scientific LLC	JJY	Class I	1982-07-13
K821335	Gemstar System	Electro-Nucleonics Laboratories, Inc.	JJE	Class I	1982-07-13