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 2026-10-26, 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 2808 of 3530

510(k) clearances, page 2808 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K871347	Wagner Revisional Femoral Hip Prosthesis	Protek, Inc.	JDI	Class II	1987-07-01
K870821	Polytron Models 1001, 1002 and 1004	Siemens Medical Solutions USA, Inc.	LLZ	Class II	1987-07-01
K870443	Kenz-Cardico 1201	Suzuken Co., Ltd.	LOS		1987-07-01
K870273	Lacey Metal Backed Patella Prosthesis	Dow Corning Wright	JWH	Class II	1987-07-01
K872225	Super Poli-Grip & Wernet's Denture Adhes. Powder	Block Drug Company, Inc.	KOT	Class I	1987-06-30
K872168	Xomed Audiant Bone Conductor at the Ear Sound Pro.	Xomed, Inc.	LXB	Class II	1987-06-30
K872101	Biofilm Trans. Pouch Ulcer & Wound Dressing	The Bfgoodrich Co.	NAD	Class I	1987-06-30
K872100	Biofilm Transorbent Ulcer and Wound Dressing	The Bfgoodrich Co.	NAD	Class I	1987-06-30
K872099	Biofilm Trans. Island, Island Ulcer & Wound Dress.	The Bfgoodrich Co.	NAD	Class I	1987-06-30
K871814	Sarmiento Forearm Nail	Depuy, Inc.	HSB	Class II	1987-06-30
K871715	Advertising and Label Change on Tambrands Tampons	Tambrands Inc.	HEB	Class II	1987-06-30
K870085	Anterior Spinal Fixation Plate	Terray Manufacturing, Inc.	KWP	Class II	1987-06-30
K865038	Surgisteel	Sutures, Ltd.	GAQ	Class II	1987-06-30
K872032	Ventrescreen (Tm) Mono	Ventrex Laboratories, Inc.	KTN	Class II	1987-06-29
K872012	Lectec Non-Invasive Pacing Electrode	Lectec Corp.	DRO	Class II	1987-06-29
K871826	Pb Video Display to Pb251 Pulse Oximeter Upgrade	Datex Division Instrumentarium Corp.	DQA	Class II	1987-06-29
K871825	Meconium Suction Catheter	Concord Laboratories, Inc.	BSY	Class I	1987-06-29
K871647	Stimulator, Ultrasound and Muscle	Amy West	IMG	Class II	1987-06-29
K871472	Kinestim Muscle Stimulator	Promatek Industries, Ltd.	IPF	Class II	1987-06-29
K871227	Les Rad Filter	M. D. Products	ITY	Class I	1987-06-29
K871142	Ultimate Protective Safety Cap (Ups Cap)	Peachtree Medical, Inc.	FMI	Class II	1987-06-29
K870810	Dorches(tm) Lifesound(tm)	Centauri Manufacturing, Inc.	DQD	Class II	1987-06-29
K870578	Nightwatch(tm) System	Buckman Co., Inc.	DSH	Class II	1987-06-29
K870214	Modified Saltex Reagent Strips	Miles Laboratories, Inc.	CHK	Class II	1987-06-29
K864984	Robinject	International Medical Products, Inc.	KZE	Class II	1987-06-29
K872271	Various Sizes & Styles of Monopolar Forceps	New England Surgical Instrument Corp.	GEN	Class I	1987-06-26
K872223	Modified Omega Compression Hip Screw System	Howmedica Corp.	KTT	Class II	1987-06-26
K872165	Elasto-Gel Occlusive Dressing	Southwest Technologies Inc	FRO	Unclassified	1987-06-26
K871963	Hot/ice Disposable Blanket	Thermo Temp, Inc.	ILO	Class II	1987-06-26
K871962	Hot/ice Dual Function Equipment	Thermo Temp, Inc.	ILO	Class II	1987-06-26
K871770	American Pharmaseal Wound Dressing	American Pharmaseal Div. Ahsc	FRO	Unclassified	1987-06-26
K871552	Ortho* Specimen Collection Cytobrush	Ortho Diagnostic Systems, Inc.	HHT	Class II	1987-06-26
K871234	Antibody Assay for Detect. of Parainfluenza Type 1	Microscan Div. Baxter Healthcare Corp.	GQS	Class I	1987-06-26
K871233	Antibody Assay for Detection of Influenza a	Microscan Div. Baxter Healthcare Corp.	GNX	Class I	1987-06-26
K871232	Antibody Assay for Detect. of Parainfluenza Type 3	Microscan Div. Baxter Healthcare Corp.	GQS	Class I	1987-06-26
K871231	Antibody Assay for Detection of Influenza B	Microscan Div. Baxter Healthcare Corp.	GNX	Class I	1987-06-26
K871230	Antibody Assay for Detec. of Resp. Syncytial Virus	Microscan Div. Baxter Healthcare Corp.	LKT	Class I	1987-06-26
K871229	Antibody Assay for Detection of Adenovirus in Cell	Microscan Div. Baxter Healthcare Corp.	GOD	Class I	1987-06-26
K871228	Antibody Assay for Detect. of Parainfluenza Type 2	Microscan Div. Baxter Healthcare Corp.	GQS	Class I	1987-06-26
K870623	Enteral Administration Set	Plasco, Inc.	FPD	Class II	1987-06-26
K872218	Cool Shades	Mattel, Inc.	HQY	Class I	1987-06-25
K872200	Hamacher Bullet Point Ophthalmic Needle	R. J. Doyle, Inc.	HMX	Class I	1987-06-25
K872084	Porocoat Mark II Total Elbow	Depuy, Inc.	JDC	Class II	1987-06-25
K871699	Tx-3(Tens)	Oms Medico, Inc.	GZJ	Class II	1987-06-25
K871666	Model Hp (or Model 1001) Transcutaneous Stimulator	Oriental Medical Supplies, Inc.	GZJ	Class II	1987-06-25
K871373	Ebv-Check(tm) Test Kit (Igg)	Diagnostic Technology, Inc.	GNP	Class I	1987-06-25
K871298	Ebna Acif Assay Kit	Granbio, Inc.	LLM	Class I	1987-06-25
K871272	Huntleigh Flowpac Fp2000	Huntleigh Technology, Inc.	DRM	Class II	1987-06-25
K870866	The Gripper(tm) Port-a-Cath Needles	Pharmacia, Inc.	FPA	Class II	1987-06-25
K863791	Subclavian, Gish Model No. Svac-Xxxx	Gish Biomedical, Inc.	DQY	Class II	1987-06-25