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 2026-10-26, 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 2720 of 3530

510(k) clearances, page 2720 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881844	Magnum 800(Tm) Management System	Medical Group	FNL	Class II	1988-07-14
K881831	Ws 800R Thermal Array Recorder	Nihon Kohden America Inc	DSF	Class I	1988-07-14
K881716	Sceptor - New Antimicrobial Agent: Cefaclor	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-07-14
K881065	Resus-Aid	Applied Convergent Technologies, Inc.	CAE	Class I	1988-07-14
K880352	Mtx Generator	Philips North America LLC	KPR	Class II	1988-07-14
K875287	H-H Flushing Reservoir	Holter-Hausner Intl.	JXG	Class II	1988-07-14
K873316	Bubble Trap-Filter Cat. No B180f37	American Omni Medical, Inc.	DTM	Class II	1988-07-14
K882618	Jedmed/polack Keratoscope Hs/sl	Gamut Ent.	HLR	Class I	1988-07-13
K882498	Extended Life Capd Transfer Set 5C4444	Baxter Healthcare Corporation	KDJ	Class II	1988-07-13
K882466	Vas-Cath Pediatric Hemofiltration Catheter	Vas-Cath, Inc.	LFK	Class II	1988-07-13
K882455	Extended Life Capd Solution Transfer Set Ic4373	Baxter Healthcare Corporation	KDJ	Class II	1988-07-13
K882388	Mr. Razor II Twin	Burney Products Corp.	LDQ		1988-07-13
K882100	Vitacuff(r) Percutaneous Infect. Control Kit	Vitaphore Corp.	LJS	Class II	1988-07-13
K882092	Clini-Care + Pressure Ulcer Treatment System	Gaymar Industries, Inc.	FNM	Class II	1988-07-13
K882010	Power Examination Table	Enochs Mfg., Inc.	LGX	Class I	1988-07-13
K881978	Enteral Feeding Tubes	Primrose Medical, Inc.	KNT	Class II	1988-07-13
K881705	Model 5000 Air-Fluidized Support System	Surgi-Med, Inc.	INX	Class II	1988-07-13
K881636	Conseal Colostomy Continence System (One-Piece)	MEDLINE INDUSTRIES, LP - Northfield	EXB	Class I	1988-07-13
K881368	Clinical Electonic Thermometers	Sheridan Catheter Corp.	FLL	Class II	1988-07-13
K880322	Dentronix Dds 5000 Dry Heat Sterilization System	Dentronix, Inc.	KMH	Class II	1988-07-13
K882677	Stat-20 Fluorometer	Weaver Medical	JZT	Class I	1988-07-12
K882641	Tecnol Catheter Leg Strap	Tecnol New Jersey Wound Care, Inc.	KNY	Class II	1988-07-12
K882534	Abbott Testpack(tm) Gonorrhea Positive Control	Abbott Medical	LIR	Class II	1988-07-12
K882513	Modified Heart*aid 97 Auto. External Defibrillator	Cardiac Resucitator Corp.	DSI	Class II	1988-07-12
K882369	Accraassay Rid Kits	Icn Immunobiologicals	DEW	Class II	1988-07-12
K882304	Digital Thermometer Sheaths (Oral and Rectal)	Abco Dealers, Inc.	FLL	Class II	1988-07-12
K882302	Ivac(r) Unvented Vol. Infusion Set Model 52080	Y	FPA	Class II	1988-07-12
K882301	Sceptor Enteric Mic/id Panel (Revised 4/88)	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-07-12
K882300	Sceptor Enteric Mic Panel (Revised 4/88)	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-07-12
K882267	Sysmex Quicklyser-II (Qls-200A)	Toa Medical Electronics USA, Inc.	GIF	Class I	1988-07-12
K882179	Emit Hva Phencyclidine Assay	Syva Co.	LCL	Unclassified	1988-07-12
K882161	Acucair Cushion Continuous Airflow System	Ssi Medical Services, Inc.	FNM	Class II	1988-07-12
K882045	High Torque Temporary Pervenous Lead W/depth Mark	Cordis Leads, Inc.	LDF	Class II	1988-07-12
K882005	Harmony Hearing Aid Models Lp, M, Ho, HF, & C	Harmony Hearing Aids, Co.	ESD	Class I	1988-07-12
K881986	Escort - Portable Patient Monitor	Medical Data Electronics	DXH	Class II	1988-07-12
K881942	Emit Hva Cocaine Metabolite Assay	Syva Co.	DIO	Class II	1988-07-12
K881908	Tracer(tm) II Blood Glucose System	Boehringer Mannheim Corp.	CGA	Class II	1988-07-12
K881782	Msi 4000 Series Bed	Med Service, Inc.	FNL	Class II	1988-07-12
K881713	Special Procedures Base Unit Model 500	Gempco, Inc.	FMT	Class II	1988-07-12
K881706	Proxima 1 Ph Monitor	Technomanagement, Inc. C/O C.G.	FFT	Class I	1988-07-12
K881273	Horizon 2000 Arrhythmia Monitoring Option	Mennen Medical, Inc.	DSI	Class II	1988-07-12
K874938	Peripheral Vascular Laboratory Assistant Model 101	Sp Innovations, Inc.	DSB	Class II	1988-07-12
K874255	Nd:yag Surgical Laser for Endo. Gastro/uro. Appli.	Minnesota Laser Corp.	LNK	Class II	1988-07-12
K874253	Nd:yag Surgical Laser for Gastro/urology Applica.	Minnesota Laser Corp.	LNK	Class II	1988-07-12
K882105	Code #D2020-Fine Needle Aspiration Biopsy System	Dianon Systems, Inc.	GAA	Class I	1988-07-11
K882669	Appollo Bath	Electric Mobility	ILK	Class II	1988-07-08
K882623	Properdin Factor B for Technicon Dpa-1(Tm) System	Technicon Instruments Corp.	JZH	Class II	1988-07-08
K882622	Ceruloplasmin for the Technicon Dpa-1(Tm) System	Technicon Instruments Corp.	JFR	Class II	1988-07-08
K882621	Complement C4 for the Technicon Dpa-1(Tm) System	Technicon Instruments Corp.	DBI	Class II	1988-07-08
K882620	Apolipoprotein for the Technicon Dpa-1(Tm) System	Technicon Instruments Corp.	MSJ	Class I	1988-07-08