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 2026-10-29, 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 2668 of 3530

510(k) clearances, page 2668 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883796	Lifecare Micro Pump	Abbott Medical	FRN	Class II	1989-02-28
K883073	N.m.d.c. User Protective Hypodermic Syringe System	National Medical Device Corp.	FMF	Class II	1989-02-28
K882249	M.i.p. - Pump	Intro-Med, Inc.	FRN	Class II	1989-02-28
K881759	Bt-1 Infusion Pump	Ferring Laboratories, Inc.	FRN	Class II	1989-02-28
K890749	Cbc-Tech (Tm) Hematology Control/multiple	R & D Systems, Inc.	JPK	Class II	1989-02-27
K890641	Acufex Cannulated Screws, Washers, Bone Plates	Acufex Microsurgical, Inc.	HRS	Class II	1989-02-27
K890607	Sutter Hospital Cpm	Sutter Corp.	BXB	Class I	1989-02-27
K890598	Molteno Implant	Iop, Inc.	KYF	Class II	1989-02-27
K890559	Nidek Ar-1200	Nidek, Inc.	HKO	Class I	1989-02-27
K890540	Abbott Clinical Chemistry Reagent Ck-Nac	Abbott Medical	CGS	Class II	1989-02-27
K890539	Sure Count Light Handle Cover	Kleen Test Products Corporation	FTA	Class II	1989-02-27
K890502	Microlite Tube Luminometer #011-902-0000	Dynatech Laboratories, Inc.	JJQ	Class I	1989-02-27
K890490	Rug Bug Wheel Chair	Sinties Scientific, Inc.	ITI	Class II	1989-02-27
K890471	Pms Angio Drape	Professional Medical Services	KKX	Class II	1989-02-27
K890409	Dade(r) Plasminogen Chromogenic Assay	Baxter Healthcare Corporation	GGP	Class II	1989-02-27
K890387	Malleable Placenta Curette	Kinetic Medical Products	HEX	Class II	1989-02-27
K890382	Compression Forceps	Kinetic Medical Products	HFW	Class II	1989-02-27
K890380	Cervical Biopsy Forceps	Kinetic Medical Products	HFB	Class I	1989-02-27
K890376	Vaginal Speculum	Kinetic Medical Products	HFD	Class II	1989-02-27
K890348	Lc, Cardiac Positioner #B5078a	General Electric Co.	IZI	Class II	1989-02-27
K890336	Glucose (God) Reagent	Alpkem Corp.	CGA	Class II	1989-02-27
K890314	Protector (Surgical Instrument)	Richard-Allan Medical Ind., Inc.	MMK	Class II	1989-02-27
K890302	Calcium Plus Procedure	Data Medical Associates, Inc.	CJY	Class II	1989-02-27
K885246	Advantage	Clark Davis Medical Systems, Inc.	GWF	Class II	1989-02-27
K885169	Stamey Sampler Spring Loaded Biopsy Needle	Boston Scientific Corporation	KNW	Class II	1989-02-27
K885130	Modified Aire-Cuf Silicone Tracheostomy Tube	Bivona Medical Technologies	JOH	Class II	1989-02-27
K885129	Modified Fome-Cuf Silicone Tracheostomy Tube	Bivona Medical Technologies	JOH	Class II	1989-02-27
K885083	Infusa-Plate(tm) Ex	Kalayjian Ent.	FRN	Class II	1989-02-27
K884926	Balance System	Chattanooga Group, Inc.	LXV	Unclassified	1989-02-27
K884889	Modified O.e.c. Univ. Self-Aligning Aceta. Comp.	Protek, Inc.	KWL	Class II	1989-02-27
K884814	Biotens	Trekk Intl.	GXY	Class II	1989-02-27
K884788	Toshiba Tct-600Xt Computed Tomography X-Ray System	Toshiba Medical Systems	JAK	Class II	1989-02-27
K884753	Modified Free T4 Radioimmunoassay Kit	Advanced Magnetics, Inc.	CEC	Class II	1989-02-27
K884565	Acufex Fixation Button	Acufex Microsurgical, Inc.	KGS	Class I	1989-02-27
K884555	Tct-600Hq Compu Tomo(ct)xray/head/whole Body Exam	Toshiba Medical Systems	JAK	Class II	1989-02-27
K884378	Dacos or Dacos Xl Clinical Chemistry Analyzer	Coulter Corp.	JJE	Class I	1989-02-27
K884071	Amplaid Emg15	Amplus Corp.	GWL	Class II	1989-02-27
K884018	Lamelli Oxygen Enriched Environment System & Tent	Lamelli Pulmonary Research Center	CAW	Class II	1989-02-27
K883407	Toray Filtryzer Bk Series	Toray Industries (America), Inc.	KDI	Class II	1989-02-27
K883324	Digicam Lhp (Digital Laser High Performance)	Siemens Gammasonics, Inc.	LMC	Class II	1989-02-27
K890701	Endothelial Growth Medium (Egm)	Clonetics Corp.	KIT	Class I	1989-02-24
K890700	Melanocyte Growth Medium (Mgm)	Clonetics Corp.	KIT	Class I	1989-02-24
K890674	Accustain(tm) - Automated Wright Giemsa Stain Set	Sigma Diagnostics, Inc.	IAF	Class I	1989-02-24
K890673	Wright-Glemsa Stain	Sigma Diagnostics, Inc.	IAF	Class I	1989-02-24
K890552	Cp&s Gavage Constainer, Disposable	Consolidated Products & Services, Inc.	KNT	Class II	1989-02-24
K890361	Kodak Min-R 2 Cassette	Eastman Kodak Company	IXA	Class II	1989-02-24
K890155	Mdp Disposable Syringe	Mediplas Marketing	FMF	Class II	1989-02-24
K890052	Biotrack Aptt Reagent Cartridge	Biotrack, Inc.	GFO	Class II	1989-02-24
K890020	Ats Lugol's Iodine Solution	Alpha-Tec Systems, Inc.	JTS	Class I	1989-02-24
K885241	Bed, Adjustable, Hospital, Folding, Field, W/o Mat	King Mfg. Co.	FNJ	Class I	1989-02-24