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 2674 of 3530

510(k) clearances, page 2674 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K890326	Hip Fracture Stem System - Fenestration Plug	Howmedica Corp.	LZN	Class II	1989-02-03
K890235	Dressing Scissors	Kinetic Medical Products	LRW	Class I	1989-02-03
K890200	Pneumatic Dorsiflexor	Medical Flotation Systems, Inc.	BXB	Class I	1989-02-03
K890170	Scissors	Dhason Brothers, Inc.	LRW	Class I	1989-02-03
K890167	Holder, Needle	Dhason Brothers, Inc.	HXK	Class I	1989-02-03
K890159	Towel Clips	Dhason Brothers, Inc.	GDO	Class I	1989-02-03
K890127	Intravascular Administration Set	Multi-Med, Inc.	FMI	Class II	1989-02-03
K890091	Modified Labsystems' Rubella Igg Eia Test Kit	Labsystems, Inc.	LFX	Class II	1989-02-03
K890076	Orthotrak	Motion Analysis Corp.	LXJ	Class II	1989-02-03
K890075	Foottrak	Motion Analysis Corp.	LXJ	Class II	1989-02-03
K890074	Spinetrak	Motion Analysis Corp.	LXJ	Class II	1989-02-03
K890034	Photometric Method, Iron (Non-Heme) (75Jiy)	American Monitor Corp.	JIY	Class I	1989-02-03
K890016	Face Mask	Anjudd Intl.	FXX	Class II	1989-02-03
K885330	Wheelchair, Mechanical	Kaye Products, Inc.	IOR	Class I	1989-02-03
K885291	Model 20-Ch Carbon Dioxide Laser W/accessories	Pfizer Laser Systems	GEX	Class II	1989-02-03
K885222	Precise Ila and Ilan Surgical Staples	3M Company	GDW	Class II	1989-02-03
K885193	Olympus Ise Module	Olympus Corp.	CGZ	Class II	1989-02-03
K885178	Kodaflex II Radiation Therapy L Cassette	Eastman Kodak Company	IXA	Class II	1989-02-03
K885035	Koagulab* 32-S Coagulation System	Ortho Diagnostic Systems, Inc.	GKP	Class II	1989-02-03
K884944	Tu Suctiontrap	Tulan Corp. C/O Richard Hamer Assoc.	BSY	Class I	1989-02-03
K884922	The Breathe Ease Nursery Vapor Tent	Cal-Trends Products	FNC	Class II	1989-02-03
K884898	Immunodot Torch Test Rubella	General Biometrics, Inc.	LFX	Class II	1989-02-03
K884863	Electra 900C Automatic Coagulation Timer	Medical Laboratory Automation Systems, Inc.	GKP	Class II	1989-02-03
K884851	Biofeedback Device Tg3, Tg4	Moe	HCC	Class II	1989-02-03
K884828	Handidam	Aseptico, Inc.	EIE	Class I	1989-02-03
K884731	Lytening 6 Sodium/potassium/ionized Calcium Analyz	Amdev, Inc.	JFP	Class II	1989-02-03
K884722	Lumineb I	Lumiscope Co., Inc.	BTI	Class II	1989-02-03
K884513	Pf Test	Medi-Tech, Inc.	GMZ	Class I	1989-02-03
K884180	Turbox Rheumatoid Factor Immunological Test System	Unipath, Ltd.	DHR	Class II	1989-02-03
K884026	Escherichia Coli 0157 Latex Agglutination Test Kit	Oxoid U.S.A., Inc.	GNA	Class I	1989-02-03
K884020	Coulter Clone B4 Monoclonal Antibody	Coulter Immunology	GKZ	Class II	1989-02-03
K883845	Resubmitted Ai 5200 Ultrasound Transducer	Phoenix Imaging	DXK	Class II	1989-02-03
K883776	Btc Chlamydia Direct Specimen Test & Control Slide	Btc Corp.	LKI	Class I	1989-02-03
K883753	Coulter Clone T1 Monoclonal Antibody	Coulter Immunology	GKZ	Class II	1989-02-03
K883710	Coulter Clone T3 Monoclonal Antibody	Coulter Immunology	GKZ	Class II	1989-02-03
K883665	Coonrad III Total Elbow	Zimmer GmbH	JDC	Class II	1989-02-03
K883556	Latex Surgical Glove (Non Sterile)	Makintech Corp.	KGO	Class I	1989-02-03
K882200	Sterile & Non-Sterile Surgeons Gloves	Taroko Ent., Ltd.	KGO	Class I	1989-02-03
K860698	The Booster	Knapps Corp.	LKY	Class II	1989-02-03
K890350	Vs-1 Silicone Implant Leads (New Serial # Tube)	Telectronics, Inc.	DTB	Class III	1989-02-02
K885156	Clinistat Sgot (Ast) Reagent Test	Kulzer GmbH	CIT	Class II	1989-02-02
K885144	Clinistat Sgpt (Alt) Serum Glutamate Pyruvate Tran	Kulzer GmbH	CKA	Class I	1989-02-02
K885082	Immunodot Rubella Test	General Biometrics, Inc.	LFX	Class II	1989-02-02
K885034	T-Uptake Microassay	Diamedix Corp.	CEE	Class II	1989-02-02
K884901	Dade(r) Prototrol Synthetic Substrate Assay Contro	Baxter Healthcare Corporation	GGN	Class II	1989-02-02
K884886	Model 250 Liquid Chromotagraphy Pump	Revvity Health Sciences, Inc.	LDM	Class I	1989-02-02
K884881	Dade Protein C Chromogenic Assay	Baxter Healthcare Corporation	GGP	Class II	1989-02-02
K884853	Biofeedback Eeg1/2, EEG Ultra Low Noise, Syc1	Moe	HCC	Class II	1989-02-02
K884852	Biofeedback Device Emg1, EMG Ultra Low Noise Opti.	Moe	HCC	Class II	1989-02-02
K884850	Biofeedback Tmg1, 4, Bio1, Pa1, 2, Ba1/ba30	Moe	HCC	Class II	1989-02-02