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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2581 of 3530

510(k) clearances, page 2581 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896947	Chiropractic Massage Pillow	Intl. Pacific Industrial Corp. (USA), Inc.	IRO	Class I	1990-01-02
K896868	Opus Phenytoin Test System	Pb Diagnostic Systems, Inc.	LGR	Class II	1990-01-02
K896860	Opus Carbamazepine Test System	Pb Diagnostic Systems, Inc.	KLT	Class II	1990-01-02
K896770	Arthrodistractor	Arthroplastics, Inc.	HRX	Class II	1990-01-02
K896692	Amdev Lytening 2 Sodium/potassium/lithium/analyzer	Baxter Healthcare Corporation	CEM	Class II	1990-01-02
K896640	Modified Fsh Enzyme Immunoassay Test Kit	Medix Biotech, Inc.	CGJ	Class I	1990-01-02
K896604	Mal Latex Examination Gloves	P.T. Maja Agung Latexindo	LYY	Class I	1990-01-02
K896553	Medx Cervical Extension Test & Rehab Machine	Medx Corp.	IKK	Class II	1990-01-02
K896526	Lytening(tm) 5, Lytening(tm) System 30	Baxter Healthcare Corporation	JGS	Class II	1990-01-02
K896522	Document(tm) Total and Direct Bilirubin Linearity	Casco Standards	JJY	Class I	1990-01-02
K896447	Autosceptor	BD Becton Dickinson Vacutainer Systems Preanalytic	LRG	Class II	1990-01-02
K896416	Dyonics Shoulder Portal System	Dyonics, Inc.	HRX	Class II	1990-01-02
K896262	Titanium Ligating Clips	Richard-Allan Medical Ind., Inc.	HBT	Class I	1990-01-02
K896202	Matrix(tm)-96	Canberra Industries, Inc.	JJJ	Class I	1990-01-02
K895878	Olympus Valvulotome W/detachable Tip	Olympus Corp.	DWX	Class II	1990-01-02
K895860	Medi-Pack	Heatmax Mfg., Inc.	IMD	Class I	1990-01-02
K895797	Imed 4100 and 4200 Disposable Infusion Device	Imed Corp.	FRN	Class II	1990-01-02
K895760	Electrical Muscle Stimulator--Pgs 2000 TENS Device	Universal Technology Systems, Inc.	IPF	Class II	1990-01-02
K895679	Cefmatzole 30 Mcg Sensi Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1990-01-02
K895660	Ansell Denta Gloves	Ansell, Inc.	LYY	Class I	1990-01-02
K895505	Kodak Surecell Chlamydia Test Kit (Add'l Uses)	Eastman Kodak Company	LJC	Class I	1990-01-02
K894121	Patient Examination Gloves	Pro-Tex Products, Inc.	LYY	Class I	1990-01-02
K893254	Dynamic System Computerized Podiatric Analyzer	Dalphi, Inc.	KHX	Class I	1990-01-02
K892779	Patient Examination Gloves	Jamuri Sdn. Bhd.	LYY	Class I	1990-01-02
K896962	Tiny Halogen Exam Light	JEDMED Instrument Company	KZF	Class I	1989-12-29
K896643	Human Growth Hormone Enzyme Immunoassay Mb-1015	Medix Biotech, Inc.	CFL	Class I	1989-12-29
K896479	Ortho* Rubella-G Antibody Elisa Test	Ortho Diagnostic Systems, Inc.	LFX	Class II	1989-12-29
K896105	Evolution Hip System	Dow Corning Wright	KWL	Class II	1989-12-29
K895917	Cyto-Stat/coulter Clone T4-Rd1/t8-Fitc Mono Anti	Coulter Immunology	GKZ	Class II	1989-12-29
K895864	Microruptor III Syst, Q-Switched Nd:yag Laser Comp	Lasag AG	LXS	Class II	1989-12-29
K894949	Sqa	United Medical Systems, Inc.	POV	Class II	1989-12-29
K894608	Model 4000 Evoked Potential Measurement System	Micro-Shev, Ltd.	GWF	Class II	1989-12-29
K891986	Multiple-Various Types of Absorbent Incontinence	Mark One Healthcare Products	KME	Class I	1989-12-29
K890349	Simultest Imk for Facs Analyzer or Facscan	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1989-12-29
K896058	Grasping Forceps	Annex Medical, Inc.	KOA	Class I	1989-12-28
K885221	Multilumen Central Venous Catheter	BD Becton Dickinson Vacutainer Systems Preanalytic	DQO	Class II	1989-12-28
K896831	Alisun Suntanning Bed	Alisun America, Ltd.	FTC	Class II	1989-12-27
K896803	Closed Wound Reservoir	Westmark, Sterile Packing Systems, Inc. (Sps)	GCY	Class I	1989-12-27
K896802	Magnet Pad	Westmark, Sterile Packing Systems, Inc. (Sps)	LXG	Class I	1989-12-27
K896801	Lap Sponge	Westmark, Sterile Packing Systems, Inc. (Sps)	EFQ	Unclassified	1989-12-27
K896792	Surgical Skin Marker	Westmark, Sterile Packing Systems, Inc. (Sps)	FZZ	Class I	1989-12-27
K896774	Streamline Vascular Access Device	Menlo Care, Inc.	FOZ	Class II	1989-12-27
K896641	Modified Prolactin Enzyme Immunoassay Test Kit	Medix Biotech, Inc.	CFT	Class I	1989-12-27
K896593	Becton Dickinson Rate Infuser II System	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1989-12-27
K896589	Manual Surgical Instruments for Titamed Antwerp	Optik	LRZ	Class I	1989-12-27
K896584	Arthroscopic Tubing Sheath	Origin Medsystems, Inc.	HRX	Class II	1989-12-27
K896390	Wilson-Cook Esophageal Prosthesis	Wilson-Cook Medical Inc.	JCQ	Class II	1989-12-27
K896191	Suntanning Bed, Inc. T12 Uva Tanning Lamps	Sunbronze	FTC	Class II	1989-12-27
K896145	Estradiol Serozyme Immunoenzymetric Assay	Serono-Baker Diagnostics, Inc.	CHP	Class I	1989-12-27
K896111	Fresenius Biocarb Hemodialysis Grade Sodium Bicarb	Fresenius USA, Inc.	KPO	Class II	1989-12-27