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 2640 of 3530

510(k) clearances, page 2640 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K893132	Phadebas Rast(r)/phadezym(r) Rast Allergen Disc	Pharmacia, Inc.	DHB	Class II	1989-06-02
K893036	Anti-Dsdna Kit, Im.77/771 (50/100 Test Kits)	Amersham Corp.	LRM	Class II	1989-06-02
K892621	Patient Examination Gloves (Latex)	Fadr Intl., Inc.	LYY	Class I	1989-06-02
K892574	Vinyl Patient Examination Gloves	Encore Products, Inc.	LYZ	Class I	1989-06-02
K892371	Chlamydiazyme Blocking Reagent	Abbott Medical	LJC	Class I	1989-06-02
K892369	Multi-Probe Head Plus	Hamilton Co	JTC	Class I	1989-06-02
K892298	Patient Exam Gloves (Mfg. Heart Credit Industrial)	B.Y.K. Trading, Inc.	LYY	Class I	1989-06-02
K892197	Alatop (Tm) Catalog # Akal1	Siemens Healthcare Diagnostics Inc.	DGC	Class II	1989-06-02
K891878	Patient Examination Gloves (Latex)	Pacific Delta Medical Supply	LYY	Class I	1989-06-02
K891839	Latex Examination Gloves	Yeou Jih Rubber Industrial Co., Ltd.	LYY	Class I	1989-06-02
K891577	Sceptor Data Management Center Software	BD Becton Dickinson Vacutainer Systems Preanalytic	LON	Class II	1989-06-02
K891339	Irri-Flo Irrigation Delivery System	Surgitek	OCX	Class II	1989-06-02
K891244	Patient Examination Gloves (Latex)	Ganda Yakin Sdn Bhd	LYY	Class I	1989-06-02
K891216	Dental Equipment Protection Devices	Pro-Safe Professional Linens, Inc.	EAZ	Class I	1989-06-02
K891081	Cmv Elisa Test System	Zeus Scientific LLC	LFZ	Class II	1989-06-02
K890711	Dual Graph (Tm) Recorder-Monitor	Somatics, LLC	DSF	Class I	1989-06-02
K890626	Rapidec Coli	Dms Products, Inc.	JSS	Class I	1989-06-02
K890430	Entainer(tm) Enteral Feeding Container	Entech, Inc.	KNT	Class II	1989-06-02
K885060	Pegasus	Pfizer Laser Systems	GEX	Class II	1989-06-02
K885029	Houva II Uva/uvb	National Biological Corp.	FTC	Class II	1989-06-02
K885026	Houva II Uvb	National Biological Corp.	FTC	Class II	1989-06-02
K884720	Germ Tube Solution	Remel Inc	JXC	Class I	1989-06-02
K884690	Kirschner Spinal Fixator Kms-1	Kirschner Medical Corp.	KWP	Class II	1989-06-02
K893212	Thermalap	O.R. Concepts, Inc.	KKX	Class II	1989-06-01
K893204	Muc-X	Island Medical	BSY	Class I	1989-06-01
K893129	Cxc Fft-1 Non-Tilt Stat Radio XRAY Tab 4 Wa Fl Tab	Continental X-Ray Corp.	IZZ	Class II	1989-06-01
K893121	Robotrac (Tm) Retractor Arm	Aesculap Instruments Corp.	GAD	Class I	1989-06-01
K893118	Aor-Sullivan Protective Overglove	Aor-Sullivan	LYU	Class I	1989-06-01
K892959	Version 4.2 Application Software	Resonex, Inc.	LNH	Class II	1989-06-01
K892835	E350 Electrocardiograph	Burdick Corp.	DPS	Class II	1989-06-01
K892810	Argedent 35Sf	Argen Precious Metals, Inc.	EJT	Class II	1989-06-01
K892709	Argedent 62 Dental Alloy	Argen Precious Metals, Inc.	EJT	Class II	1989-06-01
K891540	Edentec Model 2860 Pressure Meter	Edentec Corp.	BYE	Class II	1989-06-01
K891453	Diagnostic Ultrasound Transducer: Pve-582V	Toshiba Medical Systems	IYO	Class II	1989-06-01
K891383	Medilog 9200 EEG Replay/analysis System	Oxford Medilog, Inc.	OLZ	Class II	1989-06-01
K890604	Empi, Model 489, TENS	Empi	GZJ	Class II	1989-06-01
K890408	Additional Software to Cardiodynamic Monitor	Bomed Medical Mfg., Ltd.	DSB	Class II	1989-06-01
K890021	Sterile Polyhesive Pbs Dressing	Medtronic, Inc.	KGF	Class III	1989-06-01
K885255	Mdl-1 Lasertripter(tm)	Candela Corporation	FFK	Class II	1989-06-01
K885126	Philips Rt250 Collimator (Pk8050)	Perkins Mfg. Co.	KQA	Class II	1989-06-01
K893029	Omron Travel Massager, Model Hm-01	Omron Electronics, Inc.	ISA	Class I	1989-05-31
K892962	Patient Examination Gloves (Latex)	Hung Hsien Industrial Co., Ltd.	LYY	Class I	1989-05-31
K892675	Patient Exam Gloves (Latex) Mfg. Advance Rubber	T.C. Electronics Co.	LYY	Class I	1989-05-31
K892673	Patient Exam Gloves (Vinyl) Mfg. Precious Mountain	T.C. Electronics Co.	LYZ	Class I	1989-05-31
K892577	Sunnytex Latex Examination Gloves	Glen Nevis Co.	LYY	Class I	1989-05-31
K892558	Patient Examination Gloves (Latex)	National Trading Corp.	LYY	Class I	1989-05-31
K892557	Maytex Non-Sterile Latex Exam Glove	American Seal Co.	LYY	Class I	1989-05-31
K892441	Kendall Curity Suction Catheters	The Kendal Co.	BSY	Class I	1989-05-31
K892335	Argedent 74 Dental Alloy for Porcelain Appli.	Argen Precious Metals, Inc.	EJT	Class II	1989-05-31
K892334	Leonard Tube	Surgidyne, Inc.	KDH	Class II	1989-05-31