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 2764 of 3530

510(k) clearances, page 2764 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873790	Models 4000/6000/8000/8900 Laser for Derma/surgery	Cooper Lasersonics, Inc.	GEX	Class II	1988-01-22
K873614	Cbg Cuff Manometer	Bio-Med Devices, Inc.	BSK	Class II	1988-01-22
K873215	Companion 2800A Portable Ventilator - Modification	Medtronic, Inc.	CBK	Class II	1988-01-22
K873156	Amox Oxygen Generators	Vbm Corp.	CAW	Class II	1988-01-22
K872704	Amastim 2000	Amatech International, Inc.	GZJ	Class II	1988-01-22
K871933	Model 5050 Surgilaser for Neurosurgery Use	Lasermatic, Inc.	GEX	Class II	1988-01-22
K871876	Model 5050 Surgilaser for Pulmonary Use	Lasermatic, Inc.	LLO	Class II	1988-01-22
K871421	Model Hl-100 Portable Dc Elect. Therapeutic Unit	Futuremed Div. of Future Impex Corp.	IPF	Class II	1988-01-22
K870424	Lsp Automatic Ventilator, Model 456	Life Support Products, Inc.	BTL	Class II	1988-01-22
K864841	Water-Jel(r) Burn Dressing	Trilling Resources, Ltd.	FRO	Unclassified	1988-01-22
K874890	Quantimetrix Urine Dipstick Control	Quantimetrix Medical Industries	JJW	Class I	1988-01-21
K874851	Xl-4 Pagoda (Condoms)	Mayer Laboratories	HIS	Class II	1988-01-21
K874835	Pyridoxal-5-Phosphate Tablets	Boehringer Mannheim Corp.	CKA	Class I	1988-01-21
K874824	Capillary Columns for Gas Chromatography	Supelco, Inc.	DII	Class I	1988-01-21
K874822	Raichem(tm) Magnesium Reagent	Reagents Applications, Inc.	JGJ	Class I	1988-01-21
K874638	V-Trend Beta-Hcg Test	Texas Immunology, Inc.	JHJ	Class II	1988-01-21
K874610	Adel Model 2100 Birthing Bed	Adel Medical, Ltd.	HDD	Class II	1988-01-21
K874600	Easy-Test Aspartate Aminotransferase (Asat) #19010	Em Diagnostic Systems, Inc.	CIT	Class II	1988-01-21
K874595	Multichem (R) Magnesium Reagent	Simmler Inc	JGJ	Class I	1988-01-21
K874586	Easy-Test Alanine Aminotransferase (Alat) #19017	Em Diagnostic Systems, Inc.	CKA	Class I	1988-01-21
K874584	Triglyerides Test Kit	Ciba Corning Diagnostics Corp.	CDT	Class I	1988-01-21
K874577	Kodak Ektachem Dt Slides (Phos)	Eastman Kodak Company	CEO	Class I	1988-01-21
K874576	Kodak Ektachem Dt Slides (Mg)	Eastman Kodak Company	JGJ	Class I	1988-01-21
K874438	Stratus Vancomycin Fluorometric Enzyme Immunoassay	Baxter Healthcare Corporation	LEH	Class II	1988-01-21
K874284	Shot-Gun Isolat Proced/measurement Ck-Mb in Serum	Diagnostic Chemicals, Ltd. (USA)	JHT	Class II	1988-01-21
K874280	Lyphochek Assayed Chemistry Control (Human), i/ii	Bio-Rad	JJY	Class I	1988-01-21
K874187	A-Gent Trigllycerides Gpo	Abbott Medical	CDT	Class I	1988-01-21
K873366	Wako(tm) Pretest 5A	FUJIFILM Healthcare Americas Corporation	CDM	Class I	1988-01-21
K875156	Stainless Steel Orthopaedic Cable System	Richards Medical Co., Inc.	JDQ	Class II	1988-01-20
K875103	Bio-Feedback Limb Monitor Type Code Bl-34-1	Shield Computers, Ltd.	IKE	Class I	1988-01-20
K875053	Acromed Cancellous Bone Screw	Buckman Co., Inc.	HWC	Class II	1988-01-20
K874843	Vitalon Massager	Nexus Co., Ltd. C/O Yama Trans Co., Ltd.	ISA	Class I	1988-01-20
K874665	Securline Fine Needle Aspiration Biopsy Tray	Precision Dynamics Corporation	LRP	Class I	1988-01-20
K873684	Ace Intra Compartmental Pressure Monitor	Ace Medical	LXC	Unclassified	1988-01-20
K873601	Agc Unicompartmental Knee Prosthesis	Zimmer GmbH	HRY	Class II	1988-01-20
K873598	Laser Laparoscopy Set	Cuda Products Co.	HET	Class II	1988-01-20
K873465	Van Dellen Bacteria Filter	Van Dellen, Ltd.	FPK	Class II	1988-01-20
K873123	Lee Composite Inlay System	Lee Pharmaceuticals	EBF	Class II	1988-01-20
K870820	Ivy Commander (Model 500)	Ivy Medical, Inc.	LDR	Class II	1988-01-20
K875270	Infant Intensive Care System Vertical Height Adjus	Air-Shields, Inc.	FMT	Class II	1988-01-19
K875235	Isokinetic System, Testing and Evaluation	Mizuho Orthopedic Systems Inc	IKK	Class II	1988-01-19
K875234	Mon-a-Therm's Skin Temperature Sensor	Mon-A-Therm, Inc.	FLL	Class II	1988-01-19
K875233	Variviewer (X-Ray Film Viewer)	Diversified Diagnostic Products, Inc.	IXC	Class I	1988-01-19
K875226	Esophageal Obturator/tracheal Tube	Sheridan Catheter Corp.	CAO	Class II	1988-01-19
K875157	Shimadzu Catheterization C-Arm Stand Mh-50A	Shimadzu Precision Instruments, Inc.	JAA	Class II	1988-01-19
K875083	Kodak Kodaflex II Cassette	Eastman Kodak Company	IXA	Class II	1988-01-19
K875077	Herco Silicone Resuscitator or Sun-Med Resuscita.	Herco Products, Inc.	BTM	Class II	1988-01-19
K874934	Universal Examination Table	Imatron, Inc.	KXJ	Class II	1988-01-19
K874925	Cpe 2000 Cardio Pulmonary Ergometer	Medical Graphics Corp.	KRI	Class I	1988-01-19
K874924	Cap-35 and Cap35 F	Gish Biomedical, Inc.	DTP	Class II	1988-01-19