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 2026-10-12, 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 3245 of 3528

510(k) clearances, page 3245 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820283	Sigma 2000 Gas Chromatograph	Revvity Health Sciences, Inc.	KZQ	Class I	1982-02-23
K820281	Micro-Aire Replacement Drill Burs	Micro-Aire Surgical Instruments, Inc.	GFF	Class I	1982-02-23
K820274	Digoxin Radioimmunoassay	American Diagnostic Corp.	DPB	Class II	1982-02-23
K820227	Ster-O-Dose	Inhalation Therapy Equipment, Co.	CAF	Class II	1982-02-23
K820224	Emit Freelevel System I	Syva Co.	JRL	Class I	1982-02-23
K820148	Model 343 Hearing Aid	Telex Communications, Inc.	ESD	Class I	1982-02-23
K820116	Boundary	The Buckeye Cellulose Corp.	FYA	Class II	1982-02-23
K820104	Nupro* Gel Tray	Johnson & Johnson Professionals, Inc.	KMT	Class I	1982-02-23
K820099	Trach Tape	Stan-Pak Ent.	BTO	Class II	1982-02-23
K820085	Dade Factor Assay Reference Plasma	American Dade	GGP	Class II	1982-02-23
K827034	Intelect Model 200	Chattanooga Group, Inc.			1982-02-22
K827033	Intelect Model 700	Chattanooga Group, Inc.			1982-02-22
K820084	Clotting Time Reagent	American Dade	GJB	Class II	1982-02-22
K820061	Reversible Hydrocolloid Impression Mat	Belport Co., Inc.	ELW	Class II	1982-02-22
K820049	Cerillium	Jelrus Technical Products Corp.	EJH	Class II	1982-02-22
K820015	Urethal Cutter Clamp	Lone Star Medical Products	KOA	Class I	1982-02-22
K820008	Versatome I	Alphamedix, Inc.	HQE	Class II	1982-02-22
K813613	Rapid Ch	Dms Laboratories	JTO	Class I	1982-02-22
K813612	Rapid Zyme	Dms Laboratories	JTO	Class I	1982-02-22
K813594	Intelect Model 700	Chattanooga Group, Inc.	IMG	Class II	1982-02-22
K813593	Intelect Model 200	Chattanooga Group, Inc.	IMI	Class II	1982-02-22
K813566	Cardio-Band	Cardio-Band, Inc.	LDQ		1982-02-22
K813552	Model 3000C Caloric Irrigator	Life-Tech Intl., Inc.	ETP	Class I	1982-02-22
K813530	Hemotology Calibrator	American Dade	KSA	Class II	1982-02-22
K820179	Erika Capd Prep Kit #30-9501-5	Erika, Inc.	FKX	Class II	1982-02-19
K813181	Electroc-Gym	Electrola	IPF	Class II	1982-02-19
K813108	Model 500 Veri/500	Verite	IPF	Class II	1982-02-19
K827069	Podioscope by Arrow	Arrow X-Ray Corp.			1982-02-18
K827065	Siemens Sireskop 4	Siemens Medical Solutions USA, Inc.			1982-02-18
K820285	Syva Advance Syst. Emit-Amd Gent. Assay	Syva Co.	LCQ	Class II	1982-02-18
K820278	Intravascular Administration Set	Y	FPA	Class II	1982-02-18
K820273	4050/4051 Ultraspec	Lkb Instruments, Inc.	JJQ	Class I	1982-02-18
K820270	Raichem Got (Ast) Reagent	Reagents Applications, Inc.	CIT	Class II	1982-02-18
K820263	Kodak Ektachem Clinical Chemistry Slides	Eastman Kodak Company	CHH	Class I	1982-02-18
K820255	Bi-Level Assayed Urine Metal Control	Ortho Diagnostic Systems, Inc.	JJY	Class I	1982-02-18
K820247	External Ventricular Drainage Sys.	American Heyer Schulte	JXG	Class II	1982-02-18
K820246	Prefilled Specimen Container	Sage Products LLC	KDT	Class I	1982-02-18
K820220	Ventilator Models	Pneupac, Ltd.	CBK	Class II	1982-02-18
K820167	Laminated Karaya Gum Washers	Atlantic Surgical	EXB	Class I	1982-02-18
K820156	Their Electro Surgical Coutery Pencil	Shannon Group	GEI	Class II	1982-02-18
K820119	Podioscope by Arrow	Arrow X-Ray Corp.	KPW	Class II	1982-02-18
K820117	Automatic Tray (Act I & Act II	Burbury & Cutter Ind., Inc.	KPX	Class II	1982-02-18
K820111	Siemens Sireskop 4	Siemens Corp.	KXJ	Class II	1982-02-18
K820069	Wellcogen Group B	Burroughs Wellcome Co.	GTZ	Class I	1982-02-18
K813644	Model 2650 High Capacity Dual Syringe	Harvard Apparatus, Inc.	FRN	Class II	1982-02-18
K812612	Tns Mk I Stimulator	Edu Kit, Ltd.	GZJ	Class II	1982-02-18
K820025	Trace Analytical Reduction Gas Analyz	Trace Analytical	KZQ	Class I	1982-02-15
K820282	Ace Brand Instant Cold Pack	BD Becton Dickinson Vacutainer Systems Preanalytic	IMD	Class I	1982-02-12
K820276	Telescan T-30	Telescan Medical Systems	DXH	Class II	1982-02-12
K820275	Arthroscopic Harpoon	The Anspach Effort, Inc.	HRX	Class II	1982-02-12