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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2838 of 3529

510(k) clearances, page 2838 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863609	Single-Patient Automatic Dialysis Unit Mod. Dbb-22	International Medical Products, Inc.	FKP	Class II	1987-02-25
K863577	Doppler Unit, Sds-100A	Toshiba Medical Systems	IYN	Class II	1987-02-25
K870543	Steri-Tractor Wound Retractor	3M Company	GAD	Class I	1987-02-24
K870315	White Plume Absorbent Bandage	China National Medicines & Health Prod. I/E Corp.			1987-02-24
K870314	White Plume Gauze Sponge	China National Medicines & Health Prod. I/E Corp.	EFQ	Unclassified	1987-02-24
K870312	White Plume Surgical Gauze Face Mask	China National Medicines & Health Prod. I/E Corp.	FXX	Class II	1987-02-24
K870309	White Plume Absorbent Cotton Wool	China National Medicines & Health Prod. I/E Corp.			1987-02-24
K870308	White Plume Absorbent Gauze	China National Medicines & Health Prod. I/E Corp.	EFQ	Unclassified	1987-02-24
K870306	White Plume Triangular Bandage	China National Medicines & Health Prod. I/E Corp.			1987-02-24
K870284	Triangular Bandage	Medical Group			1987-02-24
K870283	3 X 3 Sponges, Non-Sterile	Medical Group	NAB	Class I	1987-02-24
K870282	4 X 4 Sponges, Non-Sterile	Medical Group	NAB	Class I	1987-02-24
K870258	Bioscrub Surgical Scrub Brush	K. W. Griffen Co.	GEC	Class I	1987-02-24
K870257	Porex(tm) Silicone Surgical Implants for e.n.t.	Porex Medical			1987-02-24
K870243	Burnett Tmj Appliance	Medrad, Inc.	EAG	Class II	1987-02-24
K870182	Porex(tm) Malar Implant	Porex Medical			1987-02-24
K870157	Oscillating Saw/ Reciprocating Saw/ Drill-Reamer	Micro-Aire Surgical Instruments, Inc.	KFK	Class I	1987-02-24
K870156	Flexmedics Nitinol Mammory Wire	Flexmedics			1987-02-24
K870154	Porex(tm) Tissue Expander	Porex Medical	LCJ	Unclassified	1987-02-24
K870059	Mentor Nipple Reconstruction Device	Mentor			1987-02-24
K864770	Suction Tube	New England Surgical Instrument Corp.	FFA	Class II	1987-02-24
K864177	N-D Urine Tube System (N-D Tube/cap/pipette)	Cls Co.	JXA	Class I	1987-02-24
K870441	Look Cortex Extractors	Look, Inc.	HMX	Class I	1987-02-20
K870440	Look Lens Loops	Look, Inc.	HNQ	Class I	1987-02-20
K870439	Look Irrigating Cystotomes	Look, Inc.	HNY	Class I	1987-02-20
K870438	Look Irrigating Cannulas	Look, Inc.	HMX	Class I	1987-02-20
K870437	Look Capsule Polishers/scrapers	Look, Inc.	HNZ	Class I	1987-02-20
K870436	Look Irrigating/aspirating Cannulas	Look, Inc.	HMX	Class I	1987-02-20
K870336	Salicylate Assay Kit, Catalogue Number 501-71	Diagnostic Chemicals, Ltd. (USA)	DKJ	Class II	1987-02-20
K870278	Contact Lens Case W/postive Heat Indi. Mod. #695	Ryder Intl. Corp.	LPN	Class II	1987-02-20
K870265	Kratz Nova-Sert. Soft Intraocular Lens Injector	CooperVision, Inc.	KYB	Class I	1987-02-20
K870252	Document(tm) Multi-Analyte Linearity Test Set	Casco Standards	JJY	Class I	1987-02-20
K870240	Compress and Skullcap, Head Dressing	Fraass Survival Systems, Inc.	EXR	Class II	1987-02-20
K870212	Arthroscopic Shoulder Holder	Dyonics, Inc.	HST	Class I	1987-02-20
K870206	Crystal Mask	Brunswick Mfg. Co., Inc.	BYG	Class I	1987-02-20
K870195	United Surgical Corp. Cryoptic Plus	United Surgical LLC	HPS	Class II	1987-02-20
K870194	United Surgical Corp. Diathermic Plus	United Surgical LLC	HQR	Class II	1987-02-20
K870186	Endomyocardial Biopsy Device	Mansfield Scientific, Inc.	DWZ	Class II	1987-02-20
K870144	Iron(irn) Testpack, Item No. 67659/95	Em Diagnostic Systems, Inc.	JIY	Class I	1987-02-20
K870121	Digilab Micro One Applanation Tonometer	Bio-Rad	HKX	Class II	1987-02-20
K870120	Digilab Model 1500 Perimeter	Bio-Rad	HPT	Class I	1987-02-20
K870073	Manifold Swivel Rotator Models 014320 & 014321-Tab	Clinical Connections, Inc.	DTL	Class II	1987-02-20
K870012	Triglyceride (Gpo-Trinder) Reagent	Sigma Diagnostics, Inc.	CDT	Class I	1987-02-20
K865068	Accupoint Toxo	Syva Co.	LGD	Class II	1987-02-20
K864943	Numed Balloon Wedge Pressure Catheter	Numed Inc	DQO	Class II	1987-02-20
K864896	Medicomp Inhalant Mask Elbow	Medicomp, Inc.	BZA	Class I	1987-02-20
K864891	Api Uniscept (Tm) Kb	Analytical Products, Inc.	JWY	Class II	1987-02-20
K864862	Ref. Membrane for Orion 1020 Sodium/potassium Ana.	Hf Scientific, Inc.	JGS	Class II	1987-02-20
K864834	Olympus Pk300	Olympus Corp.	JJF	Class I	1987-02-20
K864825	Amylase Colorimetric Procedure	Data Medical Associates, Inc.	JFJ	Class II	1987-02-20