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 2393 of 3531

510(k) clearances, page 2393 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K914797	Premier Cd Rechargeable	Electone, Inc.	ESD	Class I	1992-02-18
K914796	Premier Asp/cd Rechargeable	Electone, Inc.	ESD	Class I	1992-02-18
K914795	Electone/pa Rechargeable	Electone, Inc.	ESD	Class I	1992-02-18
K914559	Small Joint System	Smith & Nephew Dyonics, Inc.	HRX	Class II	1992-02-18
K914504	Cytology Brush	Surgitek Medical Engineering Corp.	FDX	Class II	1992-02-18
K914453	Universal Tibial Nail and Unreamed Tibial Nail	Synthes (USA) Products LLC	JDS	Class II	1992-02-18
K914371	Universal Femoral Nail	Synthes (USA) Products LLC	JDS	Class II	1992-02-18
K914191	Xlp Network Printing	Vortech Data, Inc.	LMD	Class I	1992-02-18
K914135	Amerlite(tm) Prolactin-30 Assay, Lan.0086/2086	Amersham Corp.	CFT	Class I	1992-02-18
K914072	Continuum Knee System (Cks)	Techmedica, Inc.	JWH	Class II	1992-02-18
K913744	Il Test(tm) Amlylase	Instrumentation Laboratory Co.	JFJ	Class II	1992-02-18
K913696	Glove-Chek Portable Fluid Leakage Sensing Device	Vertex Technical Group, Inc.	LDQ		1992-02-18
K912778	Hp-Haemophilus/pneumococcus Mic Plate	Sensititre Microbiology A Div. of Radiometer	JWY	Class II	1992-02-18
K912444	Microbact 12A System, 12B System, and 24E System	Radiometer America, Inc	LGM	Class II	1992-02-18
K911184	Scanlan/taheri Valvulotome	Scanlan Intl., Inc.	MGZ	Class II	1992-02-18
K920486	Rionet Hearing Aid Hb-53P	Authorized Hearing Systems, Inc.	ESD	Class I	1992-02-14
K920253	Medix Biotech Hcg Enzyme Immunoassay Test Kit	Medix Biotech, Inc.	JHI	Class II	1992-02-14
K920078	Affinity B12	BD Becton Dickinson Vacutainer Systems Preanalytic	CDD	Class II	1992-02-14
K915892	Cmv Igg Elisa Test	Gull Laboratories, Inc.	LFZ	Class II	1992-02-14
K915760	Modified Predictor Iic Signal Averaging ECG	Corazonic Corp.	DPS	Class II	1992-02-14
K915623	Shimadzu Whole Body X-Ray CT Scanner Sct-4500Te	Shimadzu Medical Systems	JAK	Class II	1992-02-14
K915601	Gyrex 2T-Dlx	Elscint, Inc.	LNH	Class II	1992-02-14
K915452	Anesthesia Breathing Circuit	Concord/Portex	CAI	Class I	1992-02-14
K915418	Ellagic Acid Aptt Reagent	Helena Laboratories, Corp.	GFO	Class II	1992-02-14
K915374	Cordis 6 French 0.062 I.d. Ptca Guiding Cathter	Cordis US Corp.	DQY	Class II	1992-02-14
K915348	Ebv-Vca Igm Elisa	Pharmacia Diagnostics, Inc.	LJN	Class I	1992-02-14
K915316	Aap Bone Screw	Aap International, Ltd.	HWC	Class II	1992-02-14
K915207	Disposable Radiolucent Rubber Dam Clamp	Bay Technical Products, Inc.	EEF	Class I	1992-02-14
K915195	Enzymun-Test Tsh	Boehringer Mannheim Corp.	JLW	Class II	1992-02-14
K915192	7000 Series Modular Tibial Components	Osteonics Corp.	JWH	Class II	1992-02-14
K915186	7000 Series Total Knee Patellar Components	Osteonics Corp.	JWH	Class II	1992-02-14
K915115	Guider Dasher	Target Therapeutics	DQX	Class II	1992-02-14
K914832	Surgical Apparel	W. L. Gore & Associates, Inc.	FXX	Class II	1992-02-14
K914351	Clinitron C-10	Ssi Medical Services, Inc.	IXQ	Class II	1992-02-14
K913701	Moss - Anchor Set	Moss Medical Products	FPD	Class II	1992-02-14
K913299	Sof-Flex Laparoscopic Basket	Cook Ob/Gyn	HET	Class II	1992-02-14
K912771	Acacias Pharm/pump	Acacia, Inc.	LHI	Class II	1992-02-14
K912666	Dako Elisa Rotavirus Kit- 96 Tests K440	Dako Corp.	LIQ	Class I	1992-02-14
K912643	Electrode	Skylark Device Co., Ltd.	GXY	Class II	1992-02-14
K912193	3000 Infusion Pump	Graseby Medical, Ltd.	FRN	Class II	1992-02-14
K912192	3100 Infusion Pump	Graseby Medical, Ltd.	FRN	Class II	1992-02-14
K912189	Likepak 11 Cardiac Monit/lifenet Rs100 Rec Station	Physio Control, Inc.	LOS		1992-02-14
K911835	Rapsody(tm) Real-Time Arrhythmia Processing System	Gs Microsystems	DSI	Class II	1992-02-14
K905175	Pti Annuloplasty Ring(sterile)	Pioneering Technologies, Inc.	KRH	Class II	1992-02-14
K901692	Danek Spinalscope	Danek Medical, Inc.	HRX	Class II	1992-02-14
K915613	Bone Screw 3.5 Mm	Acu Med, Inc.	HWC	Class II	1992-02-13
K913213	Single Use Lee Electrode	Aspen Laboratories, Inc.	HGI	Class II	1992-02-13
K920031	Kodak X-Omatic Ident. Camera Mammography Upgrade	Eastman Kodak Company	JAC	Class I	1992-02-12
K915746	Simplastin L	bioMerieux, Inc.	GJS	Class II	1992-02-12
K915456	Phaco 3000 Linear	Innovative Medical Systems, Inc.	HQC	Class II	1992-02-12