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 3185 of 3528

510(k) clearances, page 3185 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K828566	Vidiviewer Motorized Mass Film Viewer	Diversied P.A.			1983-01-03
K828565	Brattle R-Detect Physiological Synchronizers	Medical Electronics Corp.			1983-01-03
K828564	Computer Data Monitoring System	Siemens Medical Solutions USA, Inc.			1983-01-03
K827847	Argon Fiber Optic Catheter	Hgm, Inc.			1983-01-03
K823765	Anti Sera to Human Oroscomucoid	Kent Laboratories, Inc.	DEX	Class I	1982-12-30
K823667	Cervical Collar	Warm & Form, Orthopedic Materials	IQK	Class I	1982-12-30
K823666	Universal Wrist Splint & Forearm Splint	Warm & Form, Orthopedic Materials	ILH	Class I	1982-12-30
K823665	Rotation Boot	Warm & Form, Orthopedic Materials	KNP	Class I	1982-12-30
K823664	Universal Sling, Sling & Swathe	Warm & Form, Orthopedic Materials	ILI	Class I	1982-12-30
K823663	Abdominal Binder	Warm & Form, Orthopedic Materials	KTD	Class I	1982-12-30
K823662	Rib Belt (Universal)	Warm & Form, Orthopedic Materials	IPX	Class I	1982-12-30
K823661	Clavicle Support	Warm & Form, Orthopedic Materials	IQJ	Class I	1982-12-30
K823660	Universal Bucks Traction	Warm & Form, Orthopedic Materials	KQZ	Class I	1982-12-30
K823659	Pelvic Traction Belt	Warm & Form, Orthopedic Materials	ILZ	Class I	1982-12-30
K823658	Deluxe Knee Immobilizer(universal)	Warm & Form, Orthopedic Materials	ITQ	Class I	1982-12-30
K823629	Formed Steel Device Keep Legs Separated	Fred Sammons, Inc.			1982-12-30
K823626	Disposable Tooth Brush	Fred Sammons, Inc.	ILS	Class I	1982-12-30
K823625	Mouth Stick Kit	Fred Sammons, Inc.	ILP	Class I	1982-12-30
K823624	Holder for Mouth Stick	Fred Sammons, Inc.	ILP	Class I	1982-12-30
K823622	Insulated Thermoelastomer Mitt	Fred Sammons, Inc.	IMA	Class I	1982-12-30
K823612	Adj. Wooden Board for Writing	Fred Sammons, Inc.	ILP	Class I	1982-12-30
K823608	Pictures & Word Identification Cva Pat	Fred Sammons, Inc.	ILP	Class I	1982-12-30
K823584	Fukuda Denshi 6-Channel Auto. Electro-	Brentwood Instruments, Inc.	DPS	Class II	1982-12-30
K823583	Myotest Nerve Stimulator	Prothia USA, Inc.	BXN	Class II	1982-12-30
K823567	Immunoglobulin Assays-Igg, Iga, Igm	Syva Co.	CZP	Class II	1982-12-30
K823566	Immunoglobulin Control	Syva Co.	CZP	Class II	1982-12-30
K823533	Jacket & Set	Shiley, Inc.	DTR	Class II	1982-12-30
K823516	Esa Camera	Concept, Inc.	FWH	Class I	1982-12-30
K823500	Cholesterol Reagent	Ac Biochemical Laboratories, Inc.	CHH	Class I	1982-12-30
K823488	Electrocardiograph #334	Birtcher Corp.	DPS	Class II	1982-12-30
K823474	Enzymatic Glucose Determination	The Dow Chemical Co.	CGA	Class II	1982-12-30
K823469	Terufusion Three-Way Stopcock	Terumo Medical Corp.	FMG	Class II	1982-12-30
K823456	Oxygenators #Bos-10, 105, 5S	Bentley Laboratories, Inc.	DTZ	Class II	1982-12-30
K823435	Mon-a-Therm Myocardial Temp. Sensor	Burditt & Calkins-Siemens-Elema	KRB	Class II	1982-12-30
K823414	Holter Kit Model #5000 Series	Andover Medical, Inc.	DSH	Class II	1982-12-30
K823373	Benzing Retrograde Admin. Set	Beech Medical, Inc.	FMG	Class II	1982-12-30
K823340	Clear Vinyl Monitoring Connector	Vertex Medical Corp.	DXT	Class II	1982-12-30
K823290	Neuromedics Pacetron Heart Rate Monitor	Intermedics, Inc.	DRT	Class II	1982-12-30
K823286	Models Dpt 1000/Dpt 1000Ns	Bio-Med Corp.	DRS	Class II	1982-12-30
K823272	Venous Reservoir Bag #Bmr-1400	Bentley Laboratories, Inc.	DTN	Class II	1982-12-30
K823256	Ultra-Asept Angiographic Syringe/spare	Vertex Medical Corp.	DXT	Class II	1982-12-30
K823254	Reusable Metal Stopcock	Vertex Medical Corp.	DXT	Class II	1982-12-30
K823253	Vertex Monitoring Catheter	Vertex Medical Corp.	DXT	Class II	1982-12-30
K823238	Injection Fill Tube	Vetrex Medical Corp.	DXT	Class II	1982-12-30
K823197	Model 8300 Tester	Medicon Co., Ltd.	DRT	Class II	1982-12-30
K823192	Tuohy-Borst Adapter W/side Arm	Vertex Medical Corp.	DXT	Class II	1982-12-30
K823191	Disposable Plastic Stopcock	Vertex Medical Corp.	DXT	Class II	1982-12-30
K823190	Backstop Valve W/side Arm	Vertex Medical Corp.	DXT	Class II	1982-12-30
K823033	Electrode, Pacemaker, Permanent	Pacesetter Systems	DTB	Class III	1982-12-30
K822944	Gamma Dab[125i]pth Radioimmunoassay Kit	Travenol Laboratories, S.A.	CEW	Class II	1982-12-30