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 2683 of 3530

510(k) clearances, page 2683 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884471	Kvm Blood Cell Counter	Kvm Instruments, Inc.	GKL	Class II	1988-12-27
K884397	Pharmaseal Sterile Wound Care Dressing	Baxter Healthcare Corporation	FRO	Unclassified	1988-12-27
K884393	Modified Shiley Femoral Arterial Cannula	Shiley, Inc.	DWF	Class II	1988-12-27
K884347	Modified Disposable Coaxial Bipolar Pen	Advanced Surgical Products, Inc.	GXI	Class II	1988-12-27
K884346	Cyto-Stat/coulter Clone T11-Rd1/b1-Fitc Mono. Anti	Coulter Immunology	GKZ	Class II	1988-12-27
K884320	Propaq 106(Tm)	Protocol Systems, Inc.	DRT	Class II	1988-12-27
K884315	Labile Lysing Reagent	Helena Laboratories, Corp.	LCP	Class II	1988-12-27
K884274	Buchbinder Multiflex Guidewire	Medtronic, Inc.	DQX	Class II	1988-12-27
K884154	Transluminal Endarterectomy Device	Thomas J. Fogarty, M.D.	LIF	Class II	1988-12-27
K883934	Cell Saver Haemolite B Auto. Blood Recovery System	Haemonetics Corporation	CAC	Class II	1988-12-27
K883909	Surgical Spring Clips	Applied Vascular Devices, Inc.	DSS	Class II	1988-12-27
K883790	Surgical Clamp Inserts	Applied Vascular Devices, Inc.	DXC	Class II	1988-12-27
K883468	Q5000 St/hr Slope Modification	Quinton, Inc.	DPS	Class II	1988-12-27
K882935	Nebulizer Heater	Automatic Liquid Packaging, Inc.	CAF	Class II	1988-12-27
K880505	Ecg/respiration/arrhythmia Module for Rm-301	Ppg Industries, Inc.	DSI	Class II	1988-12-27
K882554	Meditrode Kit	Life-Tech Intl., Inc.	EGJ	Class II	1988-12-23
K885042	Sony Trinitron Color Video Monitor Pvm-1343Md	Sony Medical Electronics Co.	KQM	Class I	1988-12-22
K884930	Compax Model 40, 400, 400T	General Electric Co.	IZZ	Class II	1988-12-22
K884826	Gauze Sponge	Medical Action Industries, Inc. 306	EFQ	Unclassified	1988-12-22
K884815	Slt Clmd Contact Laser	Surgical Laser Technologies, Inc.	LLO	Class II	1988-12-22
K884750	Group a Strep, Beta-Strep	Ampcor, Inc.	GTZ	Class I	1988-12-22
K884641	Bovac Smoke Collector	Mizuho Orthopedic Systems Inc	GEI	Class II	1988-12-22
K884498	Cotube Lh Irma Assay	Bio-Rad	CEP	Class I	1988-12-22
K884403	Liquid Chromatography Columns Solid Phase Ex. Tube	Supelco, Inc.	DPM	Class I	1988-12-22
K884352	Smile-Dent Ante./post. Restorative, Light-Cured	Scientific Pharmaceuticals, Inc.	EBF	Class II	1988-12-22
K884349	Adac Viewpoint (Additional Software)	Philips North America LLC	KPS	Class II	1988-12-22
K884316	Occlusal Harmony Impression Tray	Advantage Dental Co.	EHY	Class I	1988-12-22
K884285	Model Wc-115 Mobile Bassinet	Gempco, Inc.	FMT	Class II	1988-12-22
K884283	Model Wc-107 Mobile Newborn Bed	Gempco, Inc.	FMT	Class II	1988-12-22
K884280	Model Wc-102 Newborn Bed & Equipment Cabinet	Gempco, Inc.	FMT	Class II	1988-12-22
K884277	Ad Post	J. Morita USA, Inc.	ELR	Class I	1988-12-22
K884275	Flexiflo Introducer (Direct Stick) Gastrostomy Kit	Abbott Medical	KNT	Class II	1988-12-22
K884257	Levinium	Ticomet Engineering & Consulting	EJH	Class II	1988-12-22
K884187	Indentec Drill Ra #1	Phillip C. Crawford, D.D.S.	DZA	Class I	1988-12-22
K884036	Pmt Model 1110-5 Pmt Peritoneal Catheter	PMT Corp.	JXG	Class II	1988-12-22
K883984	Hemorx Cold Pack	Bio-Dyne, Inc.	LKX	Unclassified	1988-12-22
K883939	Ortho* Syphilis-G Antibody Elisa Test	Ortho Diagnostic Systems, Inc.	LIP	Class II	1988-12-22
K883938	Ortho* Syphilis-M Antibody Elisa Test	Ortho Diagnostic Systems, Inc.	LIP	Class II	1988-12-22
K883123	Amerliite Ft4 Assay Lan.0006/2006 240/144 Test Kit	Amersham Corp.	CEC	Class II	1988-12-22
K883068	Hemodialysis Concentrates	Dove Medical Supplies	KPO	Class II	1988-12-22
K881791	Stera Disposable Syringes	Excel U.S.A.	FMF	Class II	1988-12-22
K884607	Mt/s (Software Release 3.1)	Diasonics, Inc.	LNH	Class II	1988-12-21
K884390	Intersept* Crystalloid Cardioplegia Filter	Medtronic Blood Systems, Inc.	KRJ	Class II	1988-12-21
K884262	Acs(r) Hi-Torque Gold(tm) Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1988-12-21
K884209	Usci Dorros Infusion/probing Catheter	Usci, Div. C.R. Bard, Inc.	DQY	Class II	1988-12-21
K884129	Bio-Medicus Percutaneous Cannula & Introducer Set	Bio Medicus, Inc.	DQY	Class II	1988-12-21
K884104	Usci(r) Hemaquet(tm) Introducer W/obturator	C.R. Bard Inc	DYB	Class II	1988-12-21
K883354	Variable Kv Intrex Vsk 60 - 90 Kvp	Keystone X-Ray, Inc.	EAP	Class II	1988-12-21
K882484	Cms Record and Verify System	Elekta Limited	JAD	Class II	1988-12-21
K885001	Qm300 PCR Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DCN	Class II	1988-12-20