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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2942 of 3529

510(k) clearances, page 2942 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853398	Medtronic Model 5062	Medtronic, Inc.	DTB	Class III	1985-12-04
K853294	Ccs Model Bv-114 Implantable Endocardial Bipolarpa	Cardiac Control Systems, Inc.	DTB	Class III	1985-12-04
K852976	Neg Combo Panels, Neg/uri Mic,neg Id,pos Mic	American Micro Scan			1985-12-04
K852710	Implant Elect Lead Mod 30-404 Using Polyu 90 a	Telectronics, Inc.	DTB	Class III	1985-12-04
K852654	Cardiac Communicator 2000	Creative Medical Inc.	DSI	Class II	1985-12-04
K854537	Headstrap	Life Design Systems, Inc.	BTK	Class I	1985-12-03
K854214	Multicor II 402B & 402C Multiprogram. Cardiac Pace	Cordis US Corp.	DXY	Class III	1985-12-03
K854137	Arrow Brachial Central Venous Cath-Kit W/16ga & Ec	Arrow Intl., Inc.	DQY	Class II	1985-12-03
K854132	Cook Pacemaker 332T, Series R Bipolar Cardiac Puls	Cook Pacemaker Corp.	DXY	Class III	1985-12-03
K854012	American Pharmaseal Humidair Condenser	American Pharmaseal Div. Ahsc	BYD	Class I	1985-12-03
K853965	Neoguard Chest Percussor	Cas Medical Systems, Inc.	BYI	Class II	1985-12-03
K853914	Pacesetter Sys Fast Pass Endocardial Lead 856 Inli	Pacesetter Systems	DTB	Class III	1985-12-03
K853785	Series 2000 Meds Mask	Med Systems	BSJ	Class I	1985-12-03
K853760	Adult Ventilator Tester Vt-1	Bio-Tek Instruments, Inc.	CBK	Class II	1985-12-03
K853758	Py-Rite	Golden Dental Products, Inc.	NJH	Class I	1985-12-03
K853633	TENS Conductive Media Pad	Alternative Design Systems, Inc.	GXY	Class II	1985-12-03
K853383	Cardiovascular, Thermodilution, Flow, Coronary Sin	Webster Laboratories, Inc.	DYG	Class II	1985-12-03
K853136	Model 1100 Apc(angioplasty Pressure Controller)	E.A. Fischione Instrument Mfg.	MAV	Class II	1985-12-03
K853099	L.o.n. Pres Mon Lines, Cpc Lines, Administration	L.O.N. Research, Inc.	DTL	Class II	1985-12-03
K852826	An Pressure Monitor	Ferguson Medical	CAP	Class II	1985-12-03
K852825	Tma Temperature Monitor	Ferguson Medical	FLL	Class II	1985-12-03
K852824	PMA Pressure Monitor	Ferguson Medical	CAP	Class II	1985-12-03
K851365	Sorin Biomedica Orion 30/A Cardiac Stimulator & Pm	Sorin Biomedica, Fiat, USA, Inc.	DXY	Class III	1985-12-03
K854575	Modified Am-Series Dialyzers	Asahi Kasei Medical MT Corp. Oita Works	FJI	Class II	1985-12-02
K854568	V. Mueller Pneumo-Intestinal 15 Vascular & 30 Stap	American V. Mueller	GEF	Class I	1985-12-02
K854561	Blade, Scalpel	Medelec Intl. Corp.	GES	Class I	1985-12-02
K854517	New Travenol Roller Clamp-Solution Admin. Set	Travenol Laboratories, S.A.	FKK	Class I	1985-12-02
K854512	Tubing Clamp Cat#1000-a	Rao Medical Devices, Inc.	FKK	Class I	1985-12-02
K854497	Voyageur, Butterfly One, Cadet Laurentian, Horizon	Canadian Wheelchair	IOR	Class I	1985-12-02
K854413	Malis Irrigation System	Valley Forge Scientific Corp.	GEI	Class II	1985-12-02
K854404	Rotex Screw Biopsy Needle	Meadox Surgimed, Inc.	FCG	Class II	1985-12-02
K854378	Depend Fitted Brief	Kimberly-Clark Corporation	EYQ	Class I	1985-12-02
K854281	Magnetic Retriever	Aspen Laboratories, Inc.			1985-12-02
K854215	Dynafeed	MEDLINE INDUSTRIES, LP - Northfield	KNT	Class II	1985-12-02
K854028	Audit Automated Blood Chemistry Analyzer	Verified Medical Research, Inc.	JIW	Class II	1985-12-02
K854027	Laserscope Omni Plus Photosurgical System	Laserscope	LNK	Class II	1985-12-02
K853936	1351 Uroflow Auto Start	Life-Tech Intl., Inc.	FAP	Class II	1985-12-02
K853925	Quantitative Determination of Hcg in Serum-Elisa	Nms Pharmaceuticals, Inc.	JHI	Class II	1985-12-02
K853892	Vista Med-Uristat	Vista Med	KNX	Class II	1985-12-02
K853881	The Travenol 5 Ml/hr Infusor	Travenol Laboratories, S.A.	FRN	Class II	1985-12-02
K853793	Widex Model M1	Widex Hearing Aid Co., Inc.	ESD	Class I	1985-12-02
K853767	Flospik	Medelco, Ltd.	JES	Class I	1985-12-02
K853280	Four Channel Ph Probe	Akron City Hospital	FFT	Class I	1985-12-02
K852159	New Optional Probes for Ssa-90A	Toshiba Medical Systems	ITX	Class II	1985-12-02
K852090	Sonolayer-L, Sal-77A	Toshiba Medical Systems	ITX	Class II	1985-12-02
K853775	Penox High Flow Manifold	Penox Technologies, Inc.	BYJ	Class II	1985-11-29
K853445	In a Wink Lubricating & Rewetting Drops	Ciba Vision Care	HPX	Unclassified	1985-11-29
K853433	Elf	Cardio-Respiratory	BTY	Class II	1985-11-29
K852959	Po-510 Tcpo2 Monitor	Sumitomo Electric Industries, Inc.	KLK	Class II	1985-11-29
K852908	Edec 2000	Electromed Intl., Ltd.	IZO	Class I	1985-11-29