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 2760 of 3530

510(k) clearances, page 2760 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880077	Fibrinosticon	bioMerieux, Inc.	GHH	Class II	1988-02-09
K875310	Reticulocyte Stain	Sigma Diagnostics, Inc.	KFC	Class I	1988-02-09
K875197	Optik-Aids/optic-Shop Thermal/therma Pro Lens Case	Pro-Optics LLC	LRX	Class II	1988-02-09
K874940	Calibration Reference Plasma	Baxter Healthcare Corporation	GGP	Class II	1988-02-09
K874844	Care Telstat Models: Mp 5010 and Mp 5020	Care Systems, Inc.	DRT	Class II	1988-02-09
K875263	Analytes Sodium & Potassium Assayed on Tech Ra(r)	Technicon Instruments Corp.	JGS	Class II	1988-02-08
K875084	Cabot Medical Endometrial Suction Curette	Cabot Medical Corp.	HHK	Class II	1988-02-08
K874944	Modified Prisma Shield Pit & Fissure Sealant	Dentsply Intl.	EBC	Class II	1988-02-08
K874857	Kodak Ektachem 700 Analyzer Family, Software V4.0	Eastman Kodak Company	JJE	Class I	1988-02-08
K874821	Lunar Casting Alloy for Porcelain-Fused-to-Metal	Deringer-Ney, Inc.	EJS	Class II	1988-02-08
K874774	Trousers, Pneumatic, Anti-Shock Three Bladders	Vinyl Technology, Inc.	LHX	Class II	1988-02-08
K874710	Diamond Medical, Inc. Model Dm 600	Diamond Medical, Inc.	FFT	Class I	1988-02-08
K874709	Diamond Medical, Inc. Model Dm 800	Diamond Medical, Inc.	FFT	Class I	1988-02-08
K874690	Gastroplasty Calibrating Tube & Gastrostenometer	Mentor	FFX	Class II	1988-02-08
K874388	Kodak Surecell(tm) Hcg-Urine Kit	Eastman Kodak Company	JHI	Class II	1988-02-08
K873031	Starkey Model P1 Module	Starkey Laboratories, Inc.	LRB	Class I	1988-02-08
K872817	5 Mhz Doppler Outrigger	Philips North America LLC	IYN	Class II	1988-02-08
K880274	Advanced Surgical Products Scleral Plug Forceps	Advanced Surgical Products, Inc.	HNR	Class I	1988-02-05
K875369	Model ISO-2001 Univ. Patient Isolation Circuit	Diamond Medical, Inc.	FFT	Class I	1988-02-05
K875093	New Model Mb-550 Blood Pressure Monitor	Sharp Electronics Corp.	DXN	Class II	1988-02-05
K875026	Anomaloscope Plate Test - 5 [Apt-5]	LKC Technologies, Inc.	HIT	Class I	1988-02-05
K874960	Cardiovascular Surgical Instruments	Solway, Inc.	DWS	Class I	1988-02-05
K874885	Lawrence L3000 Cardiac Output Monitor	Lawrence Medical Systems, Inc.	DPW	Class II	1988-02-05
K874853	Polystan Two Stage Catheters	Polystan C/O Vitalcor, Inc.	DWF	Class II	1988-02-05
K874852	Polystan Wire Reinforced Two Stage Catheters	Polystan C/O Vitalcor, Inc.	DWF	Class II	1988-02-05
K874815	Target Therapeutics Sterile Products	Target Therapeutics	DQO	Class II	1988-02-05
K874811	Model 5202 Micromanipulator	Coherent Medical Group	GEX	Class II	1988-02-05
K874801	Orthoderm Therapy Bed	Health Products, Inc.	FNM	Class II	1988-02-05
K874681	Swirl - a Pre-Moistened Cleaning Tissue for Eyes	Klockner Contract Packaging, Inc.	HQG	Class I	1988-02-05
K874493	Bella - Vac Irrigator	Bel-Can Industries	KQT	Class II	1988-02-05
K874338	Takeda Medical Blood Pressure Meter Model Tm-2610	A and D Engineering, Inc.	DSK	Class II	1988-02-05
K874176	Biotis (Tm) Haemophilus Ducreyi	Otisville Biopharm, Inc.	JSJ	Class I	1988-02-05
K874171	Model 5650C Cardiology Data Management System	Hewlett-Packard Co.	DQK	Class II	1988-02-05
K873990	Iras Eds Interferometric Stimulator	Randwal Instrument Co., Inc.	HLX	Class II	1988-02-05
K873955	Namic Angiographic Syringe	North American Instrument Corp.	DXT	Class II	1988-02-05
K873693	Levtech Composite Traction Tongs	Levtech, Inc.	HAX	Class II	1988-02-05
K873173	Medrad MRI Injection System	Medrad, Inc.	DXT	Class II	1988-02-05
K870884	Radially-Supported Vascular Prostheses	Intervascular, Inc.	DSY	Class II	1988-02-05
K880280	Breezy Wheelchair	Motion Designs, Inc.	IOR	Class I	1988-02-04
K880205	Edwards Orthopaedics Arthroscopes and Accessories	Baxter Healthcare Corporation	HRX	Class II	1988-02-04
K880157	Microtrak Hsv 1/Hsv 2 Culture Identi./typing Test	Syva Co.	GON	Class II	1988-02-04
K875180	V-Trend Rprl Card Test	Texas Immunology, Inc.	GMP	Class II	1988-02-04
K874914	Orthomet Orthopedic Staples	Orthomet, Inc.	JDR	Class II	1988-02-04
K874807	Extravakit	Cancer Technologies, Inc.	FMF	Class II	1988-02-04
K874747	10Cc Syringe Control Ring Set	Procedure Products, Inc.	FMF	Class II	1988-02-04
K874648	Coherent Xa-30/Sp CO2 Surgical Laser	Coherent Medical Group	GEX	Class II	1988-02-04
K874592	Thromboplastin.c	Baxter Healthcare Corporation	GJS	Class II	1988-02-04
K874429	Hemoglobin Determination Test Kit Hgb S-100 & 12	Hf Scientific, Inc.	GIQ	Class II	1988-02-04
K874298	Malcolm-Rand Microneurosurgical Cranio-XRAY Frame	Engineered Orthopedic Technologies, Inc.	HBL	Class II	1988-02-04
K873540	Aerobica - Lung Exerciser	MBA Healthcare Products, Inc.	BWF	Class II	1988-02-04