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 2299 of 3531

510(k) clearances, page 2299 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931188	Checkmate Plus Blood Glucose Meter, Test Strip,etc	Cascade Medical, Inc.	CGA	Class II	1993-05-26
K931141	Biotrol Amylase Cnpg3	Biotrol, USA, Inc.	CIJ	Class II	1993-05-26
K930961	Catheter Guidewire (Peripheral Use)	Target Therapeutics	DQX	Class II	1993-05-26
K930306	Cobas Core Lh Eia	Roche Diagnostic Systems, Inc.	CEP	Class I	1993-05-26
K930261	Rtm Rehabilitation Treadmill, Model #945-200	Biodan Medical Systems, Ltd.	IOL	Class I	1993-05-26
K930011	Uresil Valve Cutter with Interchangeable Heads	Uresil, LLC	MGZ	Class II	1993-05-26
K926590	Anago Disposable Instant Cold Pack	Anago, Inc.	IMD	Class I	1993-05-26
K926589	Anago Warm Pack	Anago, Inc.	IMD	Class I	1993-05-26
K926441	Roche Cobas(r)-Fp Reagent for Total T4 Thyrox/cali	Roche Diagnostic Systems, Inc.	KLT	Class II	1993-05-26
K926394	Vista(r) Human Luteinizing Hormone(hlh) Assay	Syva Co.	CEP	Class I	1993-05-26
K926323	H-110 Acetabular Cup System	Implex Corp.	JDI	Class II	1993-05-26
K926322	Access(r) Cortisol Reagents	Bio-Rad Laboratories Inc.	JFT	Class II	1993-05-26
K926151	Lsi6000 Thermal Therapy System	Burke Neutech, Inc.	ILO	Class II	1993-05-26
K926137	Anago Fem-Cool/fem-Cool Petite	Anago, Inc.	IMD	Class I	1993-05-26
K925707	Instrument, Manual, General Surgical	Boston Scientific Corporation	GEI	Class II	1993-05-26
K925675	Battery Pack #1015Nc	Portable Power Systems, Inc.	FLL	Class II	1993-05-26
K925674	Battery Pack #1014Nc	Portable Power Systems, Inc.	FLL	Class II	1993-05-26
K925622	Fhb, Fhb-T, Fhbflex, Fhbflex-T	Icor AB	BYD	Class I	1993-05-26
K925563	Ft Model Table W/electric Hi Lo Option E	Pro Med Mfg., Inc.	INQ	Class I	1993-05-26
K924494	Citscope, Bendable -- Modification	Citation Medical Corp.	HRX	Class II	1993-05-26
K924440	u.s. Medical Ps-7000 Dialysis Scale	U.S. Medical Corp.	KOE	Class II	1993-05-26
K924293	Heritage 10	TJN Manufacturing,Inc.	JFB	Class II	1993-05-26
K924207	Avi(tm) Model 232 Standard IV Administration Set	3M Company	FPA	Class II	1993-05-26
K924125	Cri Electronic Control System	Catheter Research C/O Burditt, Bowles & Radzius	DXX	Class II	1993-05-26
K923561	Ac-901 i.v. Infusion Drop Counter	Lamtic, Inc.	FLN	Class II	1993-05-26
K923396	Thermodyn	Nemectron Medical, Inc.	IRT	Class II	1993-05-26
K922789	King Systems Corp. Universal F Breathing Circuit	King Systems Corporation.	CAI	Class I	1993-05-26
K921925	Manual Surgical Instruments	3M Company	GCJ	Class II	1993-05-26
K921742	Ohmeda Autoclavable Bellows Assembly	GE Healthcare	BSZ	Class II	1993-05-26
K921388	Biochem 9100 Multigas Monitor Ibp Module	Biochem International, Inc.	DSK	Class II	1993-05-26
K920706	Magnetic Point Guard for Surgical Needles	Retrax	FHQ	Class I	1993-05-26
K920152	Bubble Toco	Utah Medical Products, Inc	HFM	Class II	1993-05-26
K915672	Edwards Adjustable Connectors	Scientific Spinal, Ltd.	KWP	Class II	1993-05-26
K931090	Palladius-6 Alloy Semi-Precious Alloy	Vident	EJT	Class II	1993-05-25
K931089	Vga-50 Gold Alloy	Vident	EJT	Class II	1993-05-25
K930761	Image-X 70 Intraoral X-Ray System	Afp Imaging Corp.	EAP	Class II	1993-05-25
K925276	M.i.s. Trocar-Cannula	M.I.S. Technology, Inc.	GCS	Class II	1993-05-24
K924847	Detecto Model 6700 Series	Cardinal Scale Mfg Co	FRW	Class I	1993-05-24
K922130	Hospital Kit Dk 117	Savoy Medical Supply Co., Inc.	MDM	Class I	1993-05-24
K914751	Selective Infusion II Catheter	Advanced Cardiovascular Systems, Inc.	KRA	Class II	1993-05-24
K925088	Expansion Screws	Forestadent	DYJ	Class I	1993-05-22
K930879	2.5 Watt Pulsed Dental Laser System	Sunrise Technologies, Inc.	GEX	Class II	1993-05-21
K930789	8-Watt Pulsed Dental Laser System	Sunrise Technologies, Inc.	GEX	Class II	1993-05-21
K930467	Babcock Forceps, Grasping Forceps, Needle Holder	Surgical Technologies, Inc.	GCJ	Class II	1993-05-21
K930466	Compression Clamp	Surgical Technologies, Inc.	GCJ	Class II	1993-05-21
K930465	Wire Guided Oval Dilators	Surgical Technologies, Inc.	GCJ	Class II	1993-05-21
K930296	Patpos Red	Cp Bio-Medical Corp.	IWE	Class I	1993-05-21
K930295	Patpos Compact	Cp Bio-Medical Corp.	IWE	Class I	1993-05-21
K926570	Hollister(r) Bedside Drainage Collection Syst 9878	Hollister, Inc.	KNX	Class II	1993-05-21
K926369	Walther Catheters, Male, Female	Thomasville Medical Assoc.	GBM	Class II	1993-05-21