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 2688 of 3530

510(k) clearances, page 2688 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882177	Add-on to Critical Patient Care Bed	Cardio Systems, Inc.	IOQ	Class II	1988-12-01
K884783	Raney Clip	Alto Development Corp	FZQ	Class I	1988-11-30
K884760	Shower Chair	Linido, Inc.	INM	Class I	1988-11-30
K884694	Mql 20 Nd:yag Ophthalmic Laser	California Laboratories, Inc.	LQJ	Class II	1988-11-30
K884658	Zimmer Beaded Threaded Acetabular Cup	Zimmer GmbH	KWY	Class II	1988-11-30
K884654	Alphacalf Serum	Hyclone Laboratories, Inc.	KIT	Class I	1988-11-30
K884604	Mt/s Carlson Spine Coil, Part # 100-50082500-01	Diasonics, Inc.	LNH	Class II	1988-11-30
K884603	Shoulder Transmit and Receive Coils	Diasonics, Inc.	LNH	Class II	1988-11-30
K884517	Pathfinder(tm) Chlamydia Eia Detect Kit/modified	Kallestad Diag, A Div. of Erbamont, Inc.	LJC	Class I	1988-11-30
K884302	Edwards Arthroscopic Leg Holder	Baxter Healthcare Corporation	HRX	Class II	1988-11-30
K884056	Modified Implant for Xomed Audiant Bone Conductor	Xomed, Inc.	LXB	Class II	1988-11-30
K884008	Sony Cine Video System Sme-3300	Sony Medical Electronics Co.	IZI	Class II	1988-11-30
K883964	Airlife Misty Neb Medication System W/filter	Baxter Healthcare Corporation	CAF	Class II	1988-11-30
K883941	Proforma Hip System	Orthomet, Inc.	JDI	Class II	1988-11-30
K883836	Coulter Clone Quick Stain Whole Blood Lyse-II	Coulter Immunology	GGK	Class I	1988-11-30
K883780	Xtrel, Model Number 3425	Medtronic, Inc.	GZB	Class II	1988-11-30
K883770	Resubmitted Ema Dentin Cement	G-C Intl. Corp.	EMA	Class II	1988-11-30
K883745	Irma-Count(tm) Fsh W/monoclonal Antibodies	Siemens Healthcare Diagnostics Inc.	CGJ	Class I	1988-11-30
K883696	Flo-Rester	Bio-Vascular, Inc.	DXC	Class II	1988-11-30
K883547	Ge Mr Max System	General Electric Co.	LNH	Class II	1988-11-30
K883461	Dad 16S, Data Acquistion Device 16 Ch. Series	Biohm, Inc.	GYE	Class II	1988-11-30
K883177	H 10 or Hematil 10 Blood Cell & Platelet Counter	Texas Intl. Laboratories, Inc.	GKZ	Class II	1988-11-30
K882413	Suboccipital Ice Pillow	Ferguson Medical	IME	Class I	1988-11-30
K882406	Conva-Lift	Numerical Concepts, Inc.	BXB	Class I	1988-11-30
K873826	Acromed/kaneda Anterior Spinal Instrumentation	Acromed Corp.	KWQ	Class II	1988-11-30
K884480	Biotrol Bilirubin Monoreactif	Biotrol, USA, Inc.	CIC	Class II	1988-11-29
K884433	Technicon Assist(r) Calcium Method	Technicon Instruments Corp.	CIC	Class II	1988-11-29
K884364	Labeling Changes to Bio-Cor Ext Collangen Corneal	Bausch & Lomb Pharmaceutical, Inc.	MOE	Class I	1988-11-29
K884363	Labeling Changes to Bio-Cor II Collangen Corneal	Bausch & Lomb Pharmaceutical, Inc.	MOE	Class I	1988-11-29
K884362	Labeling Changes to Fyodorov Collagen Corneal Shld	Bausch & Lomb Pharmaceutical, Inc.	HQJ	Class II	1988-11-29
K884168	Analyst Thyroxine (T4) & Thyronine Uptake Calibra.	The du Pont Co.	JIS	Class II	1988-11-29
K884138	Abbott Imx Lh	Abbott Medical	CEP	Class I	1988-11-29
K883962	Roche Reagent for Inorganic Phosphorus	Roche Diagnostic Systems, Inc.	CEO	Class I	1988-11-29
K883891	Du Pont Dimension Pseudocholinesterase Verifier	E.I. Dupont de Nemours & Co., Inc.	LAS	Class I	1988-11-29
K883890	Du Pont Dimension Pseudocholinesterase Method	E.I. Dupont de Nemours & Co., Inc.	DIH	Class I	1988-11-29
K883889	Transesophageal Echo Transducer	General Electric Co.	JOP	Class II	1988-11-29
K883867	Cervical Biopsy Instrument	Mend Technologies, Inc.	HEB	Class II	1988-11-29
K883826	Home Clinic Pregnancy Test	Vanguard Biomedical Corp.	LCX	Class II	1988-11-29
K883730	Tdx Benzodiazepines Serum	Abbott Medical	JXM	Class II	1988-11-29
K883698	Zinc Oxide Eugenol Temporary Cement	E&D Dental Manufacturing Co.	EMA	Class II	1988-11-29
K883586	Technicon Ra-100 System Potassium	Technicon Instruments Corp.	CEJ	Class II	1988-11-29
K883585	Technicon Assist Potassium	Technicon Instruments Corp.	CEJ	Class II	1988-11-29
K882755	Model 500V Vascular Spectrum Analyzer	Multigon Industries, Inc.	IYN	Class II	1988-11-29
K882751	Glass Ionomer Base	Dentsply Intl.	EJK	Class II	1988-11-29
K881303	Triton Model 100 Pulsed Doppler Blood Flowmeter	Triton Technology, Inc.	DPT	Class II	1988-11-29
K881140	Ultramark 4+ Ultrasound W/3.5 Mhz 40R Convex Array	Advanced Technology Laboratories, Inc.	IYO	Class II	1988-11-29
K884407	Tracer Skeletal Traction Pins	De Medica Mfg., Inc.	HSB	Class II	1988-11-28
K884406	Tracer Hip Pinning System	De Medica Mfg., Inc.	JDS	Class II	1988-11-28
K884369	Posterior Cervical Spine Surface Coil M1085am	General Electric Co.	LNH	Class II	1988-11-28
K883868	Model Ns242 Constant Current Peripheral Nerve Stim	Fisher & Paykel Electronics, Ltd.	BXN	Class II	1988-11-28