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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2843 of 3529

510(k) clearances, page 2843 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864360	Ldh-P (Lactic Dehydrogenase) Reagent - Sce	Trace Scientific, Ltd.			1987-02-06
K864359	Ck-Nac Reagent(creatine Kinase/n-Acetyl Cysteine)	Trace Scientific, Ltd.	CGS	Class II	1987-02-06
K864357	Ast(got) (Aspartate Aminotransferase) Reagent	Trace Scientific, Ltd.	CIT	Class II	1987-02-06
K864327	Model 304-S External Micro-Volume Infusion Pump	Medtronic, Inc.	FRW	Class I	1987-02-06
K863934	Dpc Coat-a-Count Irma Lh Kit	Siemens Healthcare Diagnostics Inc.	CEP	Class I	1987-02-06
K863834	Evident Mark 2 Apex Locator	Pulpdent Corp. of America			1987-02-06
K863508	Frantz Medical Electrode	Frantz Medical Development, Ltd.	DXR	Class II	1987-02-06
K870133	Hy Pbc Flask	Hy Laboratories, Ltd.	JSG	Class I	1987-02-05
K870132	Ivac Flow Control Administration Set	Y	LDR	Class II	1987-02-05
K870093	Medical Adhesive Tape & Bandage Using Pcce Film	Avery Intl.	KGX	Class I	1987-02-05
K870092	Medical Adhesive Tape & Bandage Using Hytrel Film	Avery Intl.	KGX	Class I	1987-02-05
K870021	Medical Adhesive Tape and Adhesive Bandage	Avery Intl.	KGX	Class I	1987-02-05
K864152	Back Saver Lift Belt/wheelchair Transfer Device	Lossing Orthopedic, Inc.	ILK	Class II	1987-02-05
K862835	CO2 Fiberoptic Delivery System/bronchoscopic Use	Cooper Lasersonics, Inc.	EOQ	Class II	1987-02-05
K870231	Kultsure	Ncs Diagnostics, Inc.	LIO	Class I	1987-02-04
K870134	Mcbride Listeria Agar W/cycloheximide, Dri & Pre	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1987-02-04
K870125	Extremity Elevator	Mizuho Orthopedic Systems Inc	HST	Class I	1987-02-04
K870124	Surgical Drapes and Accessories Using Pebax Film	Avery Intl.	KKX	Class II	1987-02-04
K870123	Surgical Drapes and Accessories Using Pcce Film	Avery Intl.	KKX	Class II	1987-02-04
K870122	Surgical Drapes and Accessories Using Hytrel Film	Avery Intl.	KKX	Class II	1987-02-04
K870091	IV Securement Device Using Pcce Thermo. Film	Avery Intl.	KGX	Class I	1987-02-04
K870090	IV Securement Device Using Hytrel Thermo. Film	Avery Intl.	KGX	Class I	1987-02-04
K870057	T1365 (Bird Seed Agar Slant)	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-02-04
K870045	Skytron Model 610-2	Skytron, LLC	INX	Class II	1987-02-04
K870020	IV Securement Device	Avery Intl.	KGX	Class I	1987-02-04
K870018	E-Z Ject Insulin Syringe	Can-Am Surgical Corp.	FMF	Class II	1987-02-04
K865089	Ferris Dynaderm Plus	Ferris Mfg. Corp.	FRO	Unclassified	1987-02-04
K864853	Omni Therm Temperature Monitor	Omni Therm, Inc.	KPD	Class II	1987-02-04
K864839	Tsh Mab Irma	BD Becton Dickinson Vacutainer Systems Preanalytic	JLW	Class II	1987-02-04
K864791	Poirier Powered Wheelchair	Roseburg SA	ITI	Class II	1987-02-04
K864789	Betaflo 2000 Piggyback System	Betaflo, Inc.	LDR	Class II	1987-02-04
K864771	Chuck Handle	New England Surgical Instrument Corp.	GEI	Class II	1987-02-04
K864721	Cryotherm	Grimm Scientific Industries, Inc.	ILJ	Class II	1987-02-04
K864661	Unifast Calcium Test	Sclavo, Inc.	CIC	Class II	1987-02-04
K864660	Model M402 EMG Monitor	Bio-Logic Devices	IKN	Class II	1987-02-04
K864659	Bio-Mega Diagnostic Coated Tube Irma Tsh	Bio Mega Diagnostic, Inc.	JLW	Class II	1987-02-04
K864627	Whiteside Ortholoc II Metal Backed Patella	Dow Corning Wright	JWH	Class II	1987-02-04
K864611	Immuno-Sure	Coulter Electronics, Inc.			1987-02-04
K864591	Hcg Solid Phase Component System	BD Becton Dickinson Vacutainer Systems Preanalytic	JHI	Class II	1987-02-04
K864569	Pododigital	Broadwest Corp.	IKE	Class I	1987-02-04
K864566	Adx(tm) Analyzer	Abbott Medical	JJQ	Class I	1987-02-04
K864522	Astra Systems Multiple Chemistry Module	Beckman Instruments, Inc.	LBS	Class I	1987-02-04
K864511	Psoralite 18400 Series	Psoralite Corp.	FTC	Class II	1987-02-04
K864510	Psoralite 12800 Series	Psoralite Corp.	FTC	Class II	1987-02-04
K864499	Podoscope	Broadwest Corp.	IKE	Class I	1987-02-04
K864445	Stat Profile 4 Analyzer + Quality Control Material	Nova Biomedical Corporation	CHL	Class II	1987-02-04
K864113	Clyde (Tm) Filtration System	Arbor Technologies, Inc.	FPB	Class II	1987-02-04
K863864	Ambulatory Infusion Pump, Model As30c	Travenol Laboratories, S.A.	FRN	Class II	1987-02-04
K863819	Chemo-Cath Intraperitoneal Catheter	Hdc Corp.	FJS	Class II	1987-02-04
K863699	Sheer Energy, Active & Silky Support Panty Hose	Hanes Group	DWL	Class II	1987-02-04