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 3172 of 3528

510(k) clearances, page 3172 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K830494	Contox Drug Screen Control	Kaulson Laboratories, Inc.	DIF	Class I	1983-03-11
K830492	Contox Durg Control	Kaulson Laboratories, Inc.	DIF	Class I	1983-03-11
K830395	Peeper	Dupaco, Inc.	BYE	Class II	1983-03-11
K830329	Esophageal Stethoscope	Science Development Corp.	BZW	Class I	1983-03-11
K830281	Skin Scrub Prep. Tray	Zoa, Inc.	FRG	Class II	1983-03-11
K830167	Holder for Bos-2S Infant Bubble Oxygena-	American Bentley	KRI	Class I	1983-03-11
K830002	Capd Color-Guard System Prepkit	Abbott Medical	FKY	Class II	1983-03-11
K823829	Ferritin Immunoradiometric Assay Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	DFB	Class II	1983-03-11
K823357	Various Cardiovascular Products	C.R. Bard Inc	DQO	Class II	1983-03-11
K830633	Lic Tilt Bed	Century Manufacturing Co.	INQ	Class I	1983-03-10
K830498	Liquid Oxygen System	Medtronic, Inc.	BYJ	Class II	1983-03-10
K830479	Abuscreen Radioimmunoassay-Barbiturate	Hoffmann-La Roche, Inc.	DKN	Class II	1983-03-10
K830443	Lateral Positioning Attachment	Berivon Co.			1983-03-10
K830436	Oticon, E-27P	Octicon Corp.	ESD	Class I	1983-03-10
K830435	Oticon, E25p	Octicon Corp.	ESD	Class I	1983-03-10
K830418	Tactaid	Audiological Engineering Corp.	LRA	Unclassified	1983-03-10
K830416	Icy Cold Ice Cap	Ladora Ent.	IME	Class I	1983-03-10
K830405	Lbi-100 37Degrees Incubator	Bionetic Laboratory Products	JTQ	Class I	1983-03-10
K830399	Coupling/valve	Khi, Inc.	BTC	Class I	1983-03-10
K830398	Tdx Methotrexate	Abbott Medical	LAO	Unclassified	1983-03-10
K830365	Kineti Count 48 Immunoassay System	Medical & Scientific Designs, Inc.	JJJ	Class I	1983-03-10
K830345	Scooter, Vehicle Motorized	Amigo Sales, Inc.	INI	Class II	1983-03-10
K830341	Salt Bridge Solution & Urine Diluent	Shaban Mfg. Co.	JIX	Class II	1983-03-10
K830324	Aircare 300	Medcom GmbH	CAW	Class II	1983-03-10
K830307	Aufranc-Turner Ats Total Hip System	Howmedica Corp.	KWL	Class II	1983-03-10
K830227	Automated Elisa Reader Lbi 300	Bionetic Laboratory Products	JTQ	Class I	1983-03-10
K830157	Digiflex Automatic Pipette	Micromedic Systems	JQW	Class I	1983-03-10
K830155	Phadebas & Phadezym Rast Allergen Discs	Pharmacia, Inc.	DHB	Class II	1983-03-10
K830055	Rich-Mar Hv 20	Rich-Mar Corp.	IPF	Class II	1983-03-10
K830003	Micro Fitness Computer	Microfit, Inc.	DXG	Class II	1983-03-10
K823863	Cyberlith IX Quantum-Unipolar Cardiac	Intermedics, Inc.	DXY	Class III	1983-03-10
K823345	Patch	Shiley, Inc.	DXZ	Class II	1983-03-10
K822721	No-Boil Solid Phase Simul Trac B12	BD Becton Dickinson Vacutainer Systems Preanalytic	CDD	Class II	1983-03-10
K837117	3M Ferlic Chest Filter, X-Ray Compensating Filter	Minnesota Mining and Mfg. Co.			1983-03-09
K837111	X Ray Tube Housing/insert	Atlantic Imaging Corp.			1983-03-09
K837107	Somatom Dri X-Ray CT Scanner	Siemens Medical Solutions USA, Inc.			1983-03-09
K837081	Microscan 771 Manipulator	Laser Industries, Ltd.			1983-03-09
K837033	Rotatable Half Beam Shielding Block Model 440	Radiation Measurements, Inc.			1983-03-09
K837028	Parkinson Neurosurgical Headclamp for Serial Angiography	Ohio Medical Instrument Co., Inc.			1983-03-09
K830565	Secura Set Secondary Admin. Set	Diatek, Inc.	FPA	Class II	1983-03-09
K830560	Exerciser, Passive, Non Measuring	Kaye Products, Inc.	ION	Class I	1983-03-09
K830559	Healthcare Model #175/176 Bed Series	G.W. Healthcare, Inc.	FNL	Class II	1983-03-09
K830496	Dmv Angler	Dmv Contact Lens Co.	KYE	Class I	1983-03-09
K830483	Coons Soft Stent	Medi-Tech, Inc.	FGE	Class II	1983-03-09
K830466	Bars, Parallel, Exercise	Kaye Products, Inc.	IOE	Class I	1983-03-09
K830456	Staple Inserter-Extractor for Arthros	Instrument Makar, Inc.	HXJ	Class I	1983-03-09
K830455	Staples Designed for Arthroscopic Surg	Instrument Makar, Inc.	JDR	Class II	1983-03-09
K830444	Sterile, All Purpose Urethral Catheter	Abco Dealers, Inc.	KOD	Class II	1983-03-09
K830400	Maddatrainer Hand Exerciser	Maddak, Inc.	ION	Class I	1983-03-09
K830366	Diamond Knife	Koi, Inc.	HNN	Class I	1983-03-09