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 2026-11-05, 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 1750 of 3531

510(k) clearances, page 1750 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K991152	Hi-Torque Balance Trek Guide Wire	Boston Scientific Corporation	DQX	Class II	1999-04-29
K991135	Soft Tissue Suture Washer	Depuy, Inc.	HTN	Class II	1999-04-29
K991092	Ebi Spinelink Anterior Cervical Spinal System	Electro-Biology, Inc.	KWQ	Class II	1999-04-29
K990906	Ferris Polymem Polywic Sterile Cavity Wound Filler	Ferris Mfg. Corp.	KMF	Class I	1999-04-29
K990866	Quinton Medtrack Cr Plus Treadmill	Quinton, Inc.	ISD	Class II	1999-04-29
K990821	Providence Cup System	Biopro, Inc.	JDI	Class II	1999-04-29
K990804	Stayfuse	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HWC	Class II	1999-04-29
K990776	Aap Cannulated Screw, 7.5Mm, 4.5Mm, 4.0Mm, 3.5Mm, 7.0Mm	AAP Implantate AG	HWC	Class II	1999-04-29
K990632	Optical Tracking System (Ots)	Radionics, Inc.	HAW	Class II	1999-04-29
K990622	Bold Screw	New Deal, S.A.	HWC	Class II	1999-04-29
K990596	Distal Radius Fracture Fixation Plate System	Avanta Orthopaedics, Inc.	HRS	Class II	1999-04-29
K990452	Orlight 2000 Surgical Laser System	Ybeam Technologies, Inc.	GEX	Class II	1999-04-29
K990356	The Bagnoli-8 EMG System	Delsys Inc.	HCC	Class II	1999-04-29
K990303	Ebi Omega 21 System	Electro-Biology, Inc.	KWP	Class II	1999-04-29
K990139	Kenstone	Kenda USA	IOR	Class I	1999-04-29
K984527	In Touch Diabetes Management Software	Lifescan, Inc.	CGA	Class II	1999-04-29
K984332	Spectra Vu 1000 Series Intraoral Camera, Spectra Vu 2000 Series Intraoral Camera, Spectra Vu Hddi Sv I Intraoral Camera,	International Technology Concepts	EIA	Class I	1999-04-29
K984171	Endopearl	Linvatec Corporation	MAI	Class II	1999-04-29
K983435	Rotorblade	Li Medical Technologies, Inc.	MAI	Class II	1999-04-29
K982418	Buechel-Pappas Modular Salvage Stem	Endotec, Inc.	MJT	Class III	1999-04-29
K991411	Gereonics Ultra-Piezo Respiratory Effort Sensor	Gereonics, Inc.	BZQ	Class II	1999-04-28
K991095	Quickcard Hcg Combo Test, Model #9014	Phamatech Inc.	JHI	Class II	1999-04-28
K990798	Autostat II Anti-Jo-1 Elisa	Cogent Diagnotics, Ltd.	LLL	Class II	1999-04-28
K990797	Autostat II Anti-Scl-70 Elisa	Cogent Diagnotics, Ltd.	LLL	Class II	1999-04-28
K990796	Autostat II Anti-Pr 3 (C-Anca)elisa, Hy*tec Anti-Pr 3 (C-Anca)elisa	Cogent Diagnotics, Ltd.	MOB	Class II	1999-04-28
K990782	Daum Neurogate Trocar	Daum Corp.	KNW	Class II	1999-04-28
K990627	Autostat II Anti-Ss-A/ro Elisa	Cogent Diagnotics, Ltd.	LLL	Class II	1999-04-28
K990626	Autostat II Anti-Ss-B/la Elisa	Cogent Diagnotics, Ltd.	LLL	Class II	1999-04-28
K990625	Autostat II Anti-Sm Elisa	Cogent Diagnotics, Ltd.	LKP	Class II	1999-04-28
K990624	Autostat II Anti-Sm/rnp Elisa	Cogent Diagnotics, Ltd.	LKO	Class II	1999-04-28
K990333	Medtronic Ps Medical Introducer Sheath 12F,14f,15f, Models 3805-012, 3805-014, 3805-015	Medtronic PS Medical	GWG	Class II	1999-04-28
K984540	Keravision Vacuum Ring System	Keravision, Inc.	HNO	Class I	1999-04-28
K984223	Blood Pressure Meter, Models Ch-491, Ch-481, Ch-471	Citizen Watch Co., Ltd.	DXN	Class II	1999-04-28
K984151	Stainless Steel Nonabsorbable Surgical Suture, Usp	Mill Pond, Inc.	GAQ	Class II	1999-04-28
K983680	Trinity II Single Chamber Dvt Pump	Delphi Consulting Group	JOW	Class II	1999-04-28
K983512	Water Treatment System for Hemodialysis	Water Vault, Inc.	FIP	Class II	1999-04-28
K991277	Modification to Immulite Myoglobin, Model Lkmy1, Lkmy5	Siemens Healthcare Diagnostics Inc.	DDR	Class II	1999-04-27
K991067	Modification of: Davidstrip Hcg	Simex Medical, Inc.	JHI	Class II	1999-04-27
K990971	Easylyte Quality Control Kit, Models 2814, 2815, 2816	Medica Corp.	JJR	Class I	1999-04-27
K990947	Modified Versapulse Select Single Wavelength, Ho: Yag and Dual Wavelength, Ho: Yag/nd: Yag Surgical Lasers and Delivery	Lumenis Ltd	GEX	Class II	1999-04-27
K990870	Redi-Test Thc	Redwood Biotech, Inc.	LDJ	Class II	1999-04-27
K990610	Abbott Tumor Marker-Mcc (Lyophilized), Model 6E21-10	Bio-Rad	JJY	Class I	1999-04-27
K990547	Pilling Weck Surgical Y Stent Forceps	Pilling Weck, Inc.	EOQ	Class II	1999-04-27
K990511	X-Tip Intraosseous Perforator	Schiff & Co.	DZM	Class I	1999-04-27
K990468	Latex Examination Glove W/ Low Protein Labeling	Top Glove Sdn. Bhd.	LYY	Class I	1999-04-27
K990422	Renu Multiplus Multi-Purpose Solution	Bausch & Lomb Incorporated	LPN	Class II	1999-04-27
K983711	Dried Gram-Negative and Gram-Positive Mic/combo Panels	Dade Microscan, Inc.	JWY	Class II	1999-04-27
K991197	Vilex/duval/orthex Cannulated Bone Screw, Models P222-Xx, S25-Xx, P227-Xx, S30-Xx, P235-Xx, S35-Xx, P240-Xx, S40-Xx, P24	Vilex, Inc.	HWC	Class II	1999-04-26
K991151	Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw	Vilex, Inc.	HWC	Class II	1999-04-26
K990384	Ezflow Continuous Nebulizer,model 1005	Piper Medical Products	CAF	Class II	1999-04-26