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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3425 of 3526

510(k) clearances, page 3425 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781795	Dialyzer, Parallel Flow Disposable	Medical, Inc.	FJG	Class II	1978-12-15
K781665	Tube, Leatherman/imbruce	National Catheter Co. Div. Mallinckrodt	GBA	Class I	1978-12-15
K781032	Aqua-Gel	Murray, Salk, Inc.	EXQ	Class II	1978-12-15
K780938	Super-Sorber	Home Healthcare Products, Inc.	EYQ	Class I	1978-12-15
K782075	Stimulator, Model 7727	Medtronic, Inc.	GZJ	Class II	1978-12-14
K780894	Airflometer	Glaxo Australia Ply., Ltd.	BZG	Class II	1978-12-14
K782016	Spirocare 108-B	Marion Laboratories, Inc.	BWF	Class II	1978-12-13
K781986	Transmitter, Model 9406 and 9401	Medtronic, Inc.	DXH	Class II	1978-12-13
K781160	Ventilator, Minilung	Thompson Respiration Products, Inc.	CBK	Class II	1978-12-13
K782026	Flat Silicone Drain	Davol, Inc.	GCY	Class I	1978-12-12
K781988	Suction Apparatus, Powered by Comp. Air	Farley, W.T.	GCX	Class II	1978-12-12
K781978	Puncture Kit, Disposalbe Vein	Arrow Intl., Inc.	FMF	Class II	1978-12-12
K781964	Compression Devices, Limb	Alba-Waldensian, Inc.	IRP	Class II	1978-12-12
K781887	9100 Daystar and 9110 Orbiter Package	Castle Co.	FSY	Class II	1978-12-12
K781846	Adapter, Catheter Sheath	Arrow Intl., Inc.	KGZ	Class I	1978-12-12
K781748	Irrigation Tray	Intermed, Inc.	EYN	Class II	1978-12-12
K781713	Adapter, C/d Suction	Novametrix Medical Systems, Inc.	BTR	Class II	1978-12-12
K781679	Monitor/mini Scope	Ipco Corp.	DPS	Class II	1978-12-12
K781678	Defibrillator, Mark II	Ipco Corp.	LDD	Class II	1978-12-12
K781637	Model IV 1500 Standard Burette	Medtronic, Inc.	FPA	Class II	1978-12-12
K781159	Ventilator, Pressure	Thompson Respiration Products, Inc.	CBK	Class II	1978-12-12
K781857	Tray, Arterial Blood Gas Sampling	Jelco Laboratories	CBT	Class I	1978-12-11
K781327	Pulse Generator, Model 240, External	Intermedics, Inc.	DTE	Class II	1978-12-11
K781161	Respirator, Bantam Model	Thompson Respiration Products, Inc.	CBK	Class II	1978-12-11
K781627	Pacing Lead Adapter Model Adb 21	R.E. Brown Co., Inc.	DTD	Class II	1978-12-08
K781626	Pacing Lead Adapter, Acv 14, Acv 23	R.E. Brown Co., Inc.	DTD	Class II	1978-12-08
K781625	Pacing Lead Model Mvm 860, Mvm 890	R.E. Brown Co., Inc.	DTB	Class III	1978-12-08
K781623	Pacing Models Mum 860, Mum 890	R.E. Brown Co., Inc.	DTB	Class III	1978-12-08
K781622	Pacing Lead Adapter Model Acs 16	R.E. Brown Co., Inc.	DTD	Class II	1978-12-08
K781621	Pacing Lead Models, Mam 1260 Mam 1290	R.E. Brown Co., Inc.	DTB	Class III	1978-12-08
K781620	Pacing Lead Models, Mdm 1060, Mdm 1090	R.E. Brown Co., Inc.	DTB	Class III	1978-12-08
K781619	Pacing Lead Models Sa, 350, Sam 500	R.E. Brown Co., Inc.	DTB	Class III	1978-12-08
K781616	Omni Stik	Unitron Corp.	CBT	Class I	1978-12-08
K782001	Rosealae	Asmb	KME	Class I	1978-12-07
K781992	Koordinat Angio	Siemens Corp.	KXJ	Class II	1978-12-07
K781991	Angioskip	Siemens Corp.	IZI	Class II	1978-12-07
K781985	Burn Pad, Dry, Sterile	Chesebrough-Pond'S U.S.A. Co.	EFQ	Unclassified	1978-12-07
K781981	Decontamination Items Bag	Medicare Industries, Inc.	FRG	Class II	1978-12-07
K781980	Respiratory Therapy Gas Pouch	Medicare Industries, Inc.	FRG	Class II	1978-12-07
K781967	Hemodialysis Concentrate, Sodiu	Renal Systems, Inc.	KPO	Class II	1978-12-07
K781952	Paper Tape, Hypo Allergenic	Johnson & Johnson Professionals, Inc.	FPX	Class I	1978-12-07
K781931	Tape, Elastoplast Elastic Tear	Beiersdorf, Inc.	FQM	Class I	1978-12-07
K781876	Isolette Incubator	Air-Shields, Inc.	FMZ	Class II	1978-12-07
K781832	Scale, Acme Digital Bedside	Acme Medical Scale Co.	FRW	Class I	1978-12-07
K781820	Gloves, Vinyl Examination	Phoenix Glove Co.	FMC	Class I	1978-12-07
K781816	Inoculator, Aim-4 Microprocessor	Axford Manufacturing, Ltd.	JSS	Class I	1978-12-07
K781812	Solution Administration, Flex Valve	Travenol Laboratories, S.A.	FPA	Class II	1978-12-07
K781800	Grip, Hospital Utility	Baka Manufacturing Co., Inc.	KMK	Class I	1978-12-07
K781796	Bedding, Disposable Hospital	Kimberly-Clark Corporation	KME	Class I	1978-12-07
K781785	i.v. Set with in-Line Filter	Cutler Laboratories, Inc.	FPA	Class II	1978-12-07