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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2482 of 3531

510(k) clearances, page 2482 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K904512	Tracet Ag 4000	Lectec Corp.	DRX	Class II	1991-01-31
K903989	Sil-Med T-Tube Drain	Sil-Med Corp.	HFL	Class II	1991-01-31
K903847	Vinyl Glove-Powederfree (Oberon Gloves Intl. Ltd)	Zest Mark Industrial Co., Ltd.	LYZ	Class I	1991-01-31
K903393	Auto First-Aid Kit for America	Hisler-Radke, Inc.	LRR	Not classified	1991-01-31
K902995	Pc-Beads Postcoital Test	Microscopy Research Innovations	HHT	Class II	1991-01-31
K902693	Wallach Flexible Endometrial Sampler	CooperSurgical, Inc.	HFF	Class II	1991-01-31
K902623	Flexiflo Stomate Extension Tube	Abbott Medical	KNT	Class II	1991-01-31
K896099	Digigraph Diagnostic Work/station	Dolphin Imaging Systems	EAG	Class II	1991-01-31
K910075	Specific Allergen Modules for Alastat Allergen Ige	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1991-01-30
K905829	Determiner Pl/determination of Phospholipids	Kamiya Biomedical Company, LLC	CEL	Class I	1991-01-30
K905777	Microzyme Thyroid Uptake Enzyme Immunoassay Kit	IMMUNOTECH s.r.o.	CEE	Class II	1991-01-30
K905773	Percutaneous Transluminal Angioplasty Catheter	Mallinckrodt Medical	LIT	Class II	1991-01-30
K905674	Lead Stylet	Cardiac Pacemakers, Inc.	DRB	Class II	1991-01-30
K905649	Gamma-Glutamyl Transferase Determination	Biochemical Trade, Inc.	JQB	Class I	1991-01-30
K905540	Respironics BIPAP Remote Control Unit	Respironics, Inc.	BZD	Class II	1991-01-30
K905493	Meristar-Mp	Meridian Diagnostics, Inc.	GSA	Class I	1991-01-30
K905432	Datascope Interlock Guide Wire Extension	Datascope Corp.	DQX	Class II	1991-01-30
K905272	Adult Star, Modification	Infrasonics Corp.	CBK	Class II	1991-01-30
K905260	Total Hip Femoral Component	Intermedics Orthopedics	LZO	Class II	1991-01-30
K905189	Baxter Angioscopy Pump Tubing Set (Model Nl)	Baxter Healthcare Corporation	DQI	Class II	1991-01-30
K905177	Stat(tm) Glove	Success Builders Intl., Inc.	LZC	Class I	1991-01-30
K905127	Latex Glove Application and Removal System	Success Builders Intl., Inc.	FMC	Class I	1991-01-30
K905048	Ace 3.5Mm Cortical Bone Screw	Ace Medical	HWC	Class II	1991-01-30
K904983	Meadox(r) Surgimed Olbert Cath Syst for Urology	Meadox Surgimed, Inc.	EZN	Class II	1991-01-30
K904948	Pm2002 Cc and Pm2002 Ec	Planmeca U.S.A. Inc	EIA	Class I	1991-01-30
K904947	Pm2002 Cc, Aristocrat and Aristocrat Deluxe	Planmeca U.S.A. Inc	BZG	Class II	1991-01-30
K904823	Flexercycle	Medmetric Corp.	ISD	Class II	1991-01-30
K904735	Danniflex Model 500Tm Cpm	Buckman Co., Inc.	BXB	Class I	1991-01-30
K904535	Lu-Tex II	Lukens Medical Corp.	GAS	Class II	1991-01-30
K904466	Model #250 Defib Cable	Cardiotronics, Inc.	LDD	Class II	1991-01-30
K904409	Medtronic(r) Model 3470 X-Trel(tm) Receiver	Medtronic, Inc.	GZF	Class II	1991-01-30
K904124	Philips Multileaf Collimator (Mlc)	Philips North America LLC	IXI	Class II	1991-01-30
K903514	Fukuda Denshi Model Lx-3100	Fukuda Denshi USA, Inc.	DSI	Class II	1991-01-30
K910148	Am130 Agc-O (Behind the Ear) Hearing Aid	Electone, Inc.	ESD	Class I	1991-01-29
K910103	Electone Bte Model Am 130 HF	Electone, Inc.	ESD	Class I	1991-01-29
K910102	Electone Bte Model Am 240 Ppl	Electone, Inc.	ESD	Class I	1991-01-29
K910101	Electone Bte Model Am 130 Pp	Electone, Inc.	ESD	Class I	1991-01-29
K910100	Electone Bte Model Am 130 D	Electone, Inc.	ESD	Class I	1991-01-29
K910099	Electone Bte Model Am 240 HF	Electone, Inc.	ESD	Class I	1991-01-29
K910096	Electone Bte Model Am900 Pp	Electone, Inc.	ESD	Class I	1991-01-29
K905811	Argenco 52Hn	Argen Precious Metals, Inc.	EJT	Class II	1991-01-29
K905761	Type III Dental Gold Alloy for Crown & Bridge App.	Argen Precious Metals, Inc.	EJT	Class II	1991-01-29
K905130	Fetal Monitoring Spiral Electrode	Graphic Controls Corp.	HGP	Class II	1991-01-29
K904931	Auto Suture(r) Permanent Purstring(tm) Applier*	United States Surgical, A Division of Tyco Healthc	GAR	Class II	1991-01-29
K904755	Acoustiq Listening Device	Krueger Laboratories	LZI	Class II	1991-01-29
K904745	Medi-Trace(r) Fetal Monitoring Spiral Electrode	Graphic Controls Corp.	HGP	Class II	1991-01-29
K904605	Titanium Coc Abutment Heads for Imz	Implant Support Systems, Inc.	DZE	Class II	1991-01-29
K902928	Device Part Number Dpi-1106 Implant	Minimatic Implant Technology	DZE	Class II	1991-01-29
K900136	Ceros 80 (Ha)	Mathys Corp.	LYC	Class II	1991-01-29
K910231	Nmr-K Fundus Laser Lens	Ocular Instruments, Inc.	HJK	Class II	1991-01-28