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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3501 of 3526

510(k) clearances, page 3501 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770148	Calibrated Grasping Tubes	Maddak, Inc.	ISD	Class II	1977-02-01
K770141	Inspirometer Respiratory Exerciser	Medi, Inc.	BWF	Class II	1977-02-01
K770137	Negative Pressure Adapter 5M1350	Travenol Laboratories, S.A.	FIL	Class II	1977-02-01
K770132	Model Lp-3 Portable Volume Ventilator	Life Products, Inc.	CBK	Class II	1977-02-01
K770123	Exercise Respiratory Gas Analyzer	Respironics, Inc.	CCK	Class II	1977-02-01
K770115	Arterial Diagnostic Unit (Adu)	Medical Electronic Devices, Inc.	DPW	Class II	1977-02-01
K770083	Lifepatch Tm ECG Electrode	Physio Control, Inc.	DRX	Class II	1977-02-01
K761342	Sma Microlyzer	Technicon Instruments Corp.	JJC	Class I	1977-02-01
K761328	Anastomasis Occluder	Medical Engineering Corp.	DWS	Class I	1977-02-01
K761304	Jtb 700 Hematology Analyzer	J.T. Baker Chemical Co.	JPJ	Class II	1977-02-01
K761219	Series II Liquid Chromatograph	Revvity Health Sciences, Inc.	KIE	Class I	1977-02-01
K761091	Tpc-Lyophilized Pooled Human Plasma	Bio/Data Corp.	JPA	Class II	1977-02-01
K760888	Model 6/60 Crt Video-Sonar	Vexilar, Inc.	KNG	Class II	1977-02-01
K770165	Micro-Mix Pipette Shaker	Maddak, Inc.	JRQ	Class I	1977-01-31
K770160	Ceramist Brush	Deringer-Ney, Inc.	KXR	Class I	1977-01-31
K770159	Neydium Npflux (for Soldering)	Deringer-Ney, Inc.			1977-01-31
K770158	Hemostat	Deringer-Ney, Inc.	EMD	Class I	1977-01-31
K770155	Alkaline Phosphatase Isoyzme Reagent Set	Gelman Instrument Co.	CJO	Class II	1977-01-31
K770152	Auto-Rinse	Dental Innovators, Inc.	EHZ	Class I	1977-01-31
K770127	Centrifichem 200Mg/dl Chol. Cal. Std.	Union Carbide Corp.	JIT	Class II	1977-01-31
K770126	Centrifichem Choles. Calib. Std. Set	Union Carbide Corp.	JIT	Class II	1977-01-31
K770121	Manuel Bilirubin Reagent Set	Harleco	CIG	Class II	1977-01-31
K770090	Blachly Bite Blok & Cheek Filler	P.H. Blachly, M.D.	JXL	Class II	1977-01-31
K761327	IV Sets 2000 Series (Hs-200,2L0,220)	Extracorporeal Medical Specialities, Inc.	FPA	Class II	1977-01-31
K761023	Simulator, 10 Lead ECG	Birtcher Corp.	DPS	Class II	1977-01-31
K770170	Maddatherm Paraffin Bath	Techhnilab Instruments, Inc.	IMC	Class II	1977-01-28
K770169	Beeson Automaddak Feeder	Techhnilab Instruments, Inc.	ILC	Class I	1977-01-28
K770167	Knee Separator	Bel-Art Products	IQI	Class I	1977-01-28
K770166	Manoy Walking Aid	Maddak, Inc.	ITJ	Class I	1977-01-28
K770164	Finger Muscle Tester	Bel-Art Products	ISD	Class II	1977-01-28
K770146	Swivel Head Adjustable Crutch	Maddak, Inc.	IPR	Class I	1977-01-28
K770145	Yorkhill Chair	Maddak, Inc.	IQC	Class II	1977-01-28
K770144	Rheumatoid Hand Gym	Maddak, Inc.	ION	Class I	1977-01-28
K770131	Lew Prosthetic Locking Device	Howmedica Corp.	DZL	Class II	1977-01-28
K770129	Sprint S-2 Instru. Center (Model 92329)	Chemetron Health Systems	EBW	Class I	1977-01-28
K770120	Mouth Wash Tray	Pharmaseal Div., Baxter Healthcare Corp.	FMA	Class I	1977-01-28
K770117	Hygienic 5 & 6 Rubber Dam Frame	Hygienic Dental Mfg., Co., the	EJE	Class I	1977-01-28
K770116	Porta-Pro Tooth Polisher	Porta-Pro, Inc.	JEQ	Class I	1977-01-28
K770113	Estilux UV System	Degussa Dental, Inc.	EBZ	Class II	1977-01-28
K761147	Reliance Mod-U-Line M-700	F. & F. Koenigkramer	FPO	Class II	1977-01-28
K761099	Dover Hyperalimentation Dressing Chng Kt	Will Ross Co.	FRL	Class I	1977-01-28
K761098	Filter Devices	Arrow Intl., Inc.	FMI	Class II	1977-01-28
K761080	Isolation Gown Pack	American Hospital Supply	FYC	Class II	1977-01-28
K760857	Tr-3 Transmitter	Burdick Corp.	DXH	Class II	1977-01-28
K770161	Microfenestrated Hip Replacement Compon.	Medishield, Inc.	JDG	Class II	1977-01-26
K770134	Lightcast II Stockinette	Solar Laboratories, Inc.	ITG	Class I	1977-01-26
K770133	Lightcast II Casting System (Modified)	Solar Laboratories, Inc.	ITG	Class I	1977-01-26
K770130	B.g. Flexible Nail System	Howmedica Corp.	JDS	Class II	1977-01-26
K770128	B.g. Compression System	Howmedica Corp.	HRS	Class II	1977-01-26
K770124	Pre-Rolled Impervious Stockinette	National Patent Development Corp.			1977-01-26