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 2367 of 3531

510(k) clearances, page 2367 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K911577	Hypotrans Model 750	Martin Mclane Medical	KDK	Class II	1992-07-08
K921935	Thyroxine (T4) Coated Tube Ria	Monobind, Inc.	CDX	Class II	1992-07-07
K921558	Medtronic Models 3983A and 3983B Resume Leads	Medtronic, Inc.	GZB	Class II	1992-07-07
K920765	Emd Transtelephonic Recorder and Receiver # 1200	Electronic Monitoring Devices, Inc.	DXH	Class II	1992-07-07
K920636	Dade Urine Chemistry Control Levels I and II	Baxter Diagnostics, Inc.	JJY	Class I	1992-07-07
K920294	Smi Model 210 Ambulatory ECG Monitoring System	Stuart Medical, Inc.	LOS		1992-07-07
K922412	ECG Modulator	Maguire Ent., Inc.	DXH	Class II	1992-07-06
K921567	Coulter Mh017	Coulter Electronics, Inc.	GKZ	Class II	1992-07-06
K920990	Life-Tel L.b.e.(life-Pak 5/10 Battery Eliminator)	Raco Products Co.	LDD	Class II	1992-07-06
K905555	A-Zilicone	Oticon, Inc.	ESD	Class I	1992-07-06
K922657	Aga Trach Ties	Aga Medical Products, Inc.	CBH	Class I	1992-07-02
K922229	Olympus Triglyceride Reagent	Olympus Corp.	CDT	Class I	1992-07-02
K922180	Lewicky O.r.s. Tubing	O.R. Specialties, Inc.	KYG	Class I	1992-07-02
K921958	Elisa Tube Tsh Test	Bio Clinic Co.	JLW	Class II	1992-07-02
K921794	Ceradelta 2	Metalor Dental USA Corp.	EJT	Class II	1992-07-02
K921654	Mclean-Stock Percutaneous T-Tube Set	Cook Inc.	FGE	Class II	1992-07-02
K921639	Bias Total Hip System 300-Mm Femoral Stem	Zimmer GmbH	LPH	Class II	1992-07-02
K921631	Cvis Insight Imaging Catheter for Intraluminal	Cardiovascular Imaging Systems, Inc.	ITX	Class II	1992-07-02
K921623	Vitadur Alpha Porcelain	Vident	EIH	Class II	1992-07-02
K921622	Alphatec Compression Hip Screw System	Alphatec Spine, Inc.	HRS	Class II	1992-07-02
K921619	Dental Porcelain	Dentsply Intl.	EIH	Class II	1992-07-02
K921460	Storz Premiere/premiere Microvit Microsurg Systems	Storz Instrument Co.	HQE	Class II	1992-07-02
K921320	Elios Diode Ophthalmic Laser	Marco Ophthalmic, Inc.	GEX	Class II	1992-07-02
K921298	Model Mm-2405 and Mm-2410 Copper Vapor Laser	Cj Laser Corp.	GEX	Class II	1992-07-02
K920890	Operating Table System-Betamaquet 1140	Stierlen-Maquet AG	FQO	Class I	1992-07-02
K920443	Minineb	Vortran Medical Technology 1, Inc	CAF	Class II	1992-07-02
K920045	Duratech Hospital Towel	Techstyles	KKX	Class II	1992-07-02
K915860	Linear Peripheralvascular Ultrsound Probe	Biosound, Inc.	ITX	Class II	1992-07-02
K915715	Cine Recall Function/opus 1 Real Time Scanner	Ausonics Pty, Ltd.	IYO	Class II	1992-07-02
K915451	Multispiro-Sx	Multispiro, Inc.	BZG	Class II	1992-07-02
K914692	Urinary Diversion Evacuating Catheter	Cook Incorporated	EXD	Class II	1992-07-02
K914272	Koko Spirometer	Ferraris Respiratory, Inc.	BZG	Class II	1992-07-02
K913749	Edentrace Airflow 3171/Sleep Lab Airflow 3170	Edentec Corp.	BZQ	Class II	1992-07-02
K913681	Multispiro-Breeze	Multispiro, Inc.	BZC	Class II	1992-07-02
K922827	Otosonic Acs K	Beltone Electronics Corp.	ESD	Class I	1992-07-01
K922619	Digitizer, Model # 3-000A-1518	Lorad Medical Systems, Inc.	IZH	Class II	1992-07-01
K922475	Bactec 9120 System	BD Becton Dickinson Vacutainer Systems Preanalytic	MDB	Class I	1992-07-01
K921961	Sdmo Applicator Code: Asn.8236	Medi-Physics Inc. dba Nycomed Amersham Imaging	IWJ	Class I	1992-07-01
K921877	Ad/v Spooler	Adaptive Video, Inc.	LMD	Class I	1992-07-01
K921743	Kodak Ektascan 2180 Laser Printer	Eastman Kodak Company	LMC	Class II	1992-07-01
K921707	Pentax Naso-Pharyngo-Laryngoscope Fnl-15P2/15rp2	Pentax Precision Instrument Corp.	EOB	Class II	1992-07-01
K921692	Integrated Video System	Citation Medical Corp.	HRX	Class II	1992-07-01
K921563	Cardiometrics Flowire/flomap System	Cardio Metrics, Inc.	ITX	Class II	1992-07-01
K921139	Healey Revision Component System	Zimmer GmbH	JDL	Class III	1992-07-01
K920946	Urological Balloon Dilatation Catheter	Boston Scientific Corporation	EZN	Class II	1992-07-01
K920807	Sunglasses	Libby Lee Toys, Inc.	HQY	Class I	1992-07-01
K920153	Thermuff Bag	Techstyles	KDC	Class I	1992-07-01
K915593	Transducer Protector	United Pharmaceutical and Medical Supply Co.	FIB	Class II	1992-07-01
K915225	Megacart	Siemens Burdick, Inc.	LOS		1992-07-01
K914733	Ttl Medicated Dressing	Medimix Products, Inc.	KGX	Class I	1992-07-01