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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1751 of 3531

510(k) clearances, page 1751 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990327	Reticone System for Epics Xl Flow Cytometry Systems	Coulter Corp.	GKZ	Class II	1999-04-26
K983776	Evenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual Breast Pump	Evenflo Company, Inc.	HGX	Class II	1999-04-26
K983588	Sperm Washing Medium, Modified Sperm Washing Medium	FUJIFILM Biosciences Inc.	MQL	Class II	1999-04-26
K991294	Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free Insulin Delivery System	Medi-Ject Corp.	KZE	Class II	1999-04-23
K991138	Lysta Lc Curing Light, Model Lc 2500C/ba	Lysta A/S	EBZ	Class II	1999-04-23
K991097	Pbn Drainage Catheter Guidewires	Medical Device Technologies, Inc.	KNY	Class II	1999-04-23
K991044	Dermagrip Powder Free Latex Examination Glove, Non Sterile (Protein Content Labeling)	Wrp Specialty Products Sdn. Bhd.	LYY	Class I	1999-04-23
K991029	Rapidflap Cranial Clamp	Biomet Microfixation	GXN	Class II	1999-04-23
K990982	Cavit Lc	Espe Dental AG	EBF	Class II	1999-04-23
K990584	Gauze Sponges: Laparotomy Sponge, X-Ray Detectable	Broadline Medical Industries	EFQ	Unclassified	1999-04-23
K990527	Kleenhands Powdered Latex Examination Gloves	Ssn Gloves (M) Sdn Bhd	LYY	Class I	1999-04-23
K990526	Kleenhands Powderfree Latex Examination Gloves with Protein Labeling Claim	Ssn Gloves (M) Sdn Bhd	LYY	Class I	1999-04-23
K990486	Nitrile Examination Gloves, Non-Sterile, Powdered, Blue Color.	Alliance Rubber Products Sdn. Bhd.	LZA	Class I	1999-04-23
K990485	Nitrile Examination Gloves, Non-Sterile, Powdered, Green Color	Alliance Rubber Products Sdn. Bhd.	LZA	Class I	1999-04-23
K990459	Ebi Vuecath Endoscopic Systen	Electro-Biology, Inc.	HRX	Class II	1999-04-23
K990427	Arsoft Nitrile Examination Gloves, Non-Sterile Powder Free	Alliance Rubber Products Sdn. Bhd.	LZA	Class I	1999-04-23
K990425	Sidekick Infusion Kit	Halyard Health	FRN	Class II	1999-04-23
K983579	Synthetic Serum Substitute (Sss)	FUJIFILM Biosciences Inc.	MQL	Class II	1999-04-23
K983451	Challenge Test Pack	North American Science Assoc., Inc.	JOJ	Class II	1999-04-23
K981311	Cowboy Xv	Kci New Technologies, Inc.	JOW	Class II	1999-04-23
K991195	Carevent Bls, Carevent Bls+, Carevent Als, Carevent Als+, and Carevent Atv	O-Two Systems Intl., Inc.	BTL	Class II	1999-04-22
K991027	Bi-Directional Tunneler	Impra, Inc.	DSY	Class II	1999-04-22
K990722	Etest for Cefuroxime	Ab Biodisk	JWY	Class II	1999-04-22
K990312	Avia Pain Medication Delivery System	Amtec Medical	MEA	Class II	1999-04-22
K990214	Fluoronav Module for the Stealthstation System	Surgical Navigation Technologies, Inc.	HAW	Class II	1999-04-22
K990948	S575 Intraoral Docking Dental Camera	Sopro	EIA	Class I	1999-04-21
K990916	Indirect Fluorescence Assay for Anti-Native DNA Igg Antibody	Stellar Bio Systems, Inc.	KTL	Class II	1999-04-21
K990915	Indirect Fluorescence Assay for Anti-Nuclear Antibodies Igg Antibody	Stellar Bio Systems, Inc.	DHN	Class II	1999-04-21
K990858	Lypochek Coagulation Control, Model Nos. 787, 788, 789	Bio-Rad	GGN	Class II	1999-04-21
K990775	Ureteral Access Sheath Set	Applied Medical Resources Corp	FED	Class II	1999-04-21
K990757	Cantor & Silver 5X Tinted (Hioxifilcon a) Soft (Spherical & Toric) Daily Wear Contact Wear Contact Lens, Tinted (Transpa	Cantor & Silver, Ltd.	LPL	Class II	1999-04-21
K990371	Diabetic Needle Disposal, Model # Pmsm - 950	Post Medical, Inc.	FMI	Class II	1999-04-21
K990367	Pdq and Pdq-Ti Abutment	Vident	DZE	Class II	1999-04-21
K990206	Serim Blood Leak Test Strip	Serim Research Corp.	FJD	Class II	1999-04-21
K990175	Sheathes (Non-Latex), Sterile	Sheathing Technologies Inc	ITX	Class II	1999-04-21
K984436	Pvs Basics	Paragon Vision Sciences, Inc.	HQD	Class II	1999-04-21
K984156	Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7000Tx W/fluro Option	Shimadzu Medical Systems	JAK	Class II	1999-04-21
K983732	Thorax Fd and Multix Fd	Siemens Medical Solutions USA, Inc.	MQB	Class II	1999-04-21
K983456	Ensite 3000 System	Endocardial Solutions, Inc.	MTD	Class II	1999-04-21
K982413	Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/filters	Gambro Healthcare	KDI	Class II	1999-04-21
K991130	Flexplug	Grace Medical, Inc.	LZU	Unclassified	1999-04-20
K990939	Fasttake Compact Blood Glucose Monitoring System	Selfcare, Inc.	CGA	Class II	1999-04-20
K990754	Carbon Dioxide - L3k Assay, Catalogue Number 299-30/40/50	Sekisui Diagnostics P.E.I. Inc.	KHS	Class II	1999-04-20
K990387	Endometrial Sampler	U.A. Medical Products, Inc.	HHK	Class II	1999-04-20
K984589	Phototherapy Lamp	Medela AG	LBI	Class II	1999-04-20
K983338	Freiburg Flap Applicator Set, Part Number 089.095	Nucletron BV	JAQ	Class II	1999-04-20
K982053	EEG Electrodes Model 445 Series	Class A Ent.	GXY	Class II	1999-04-20
K981995	Quickdraw Venous Cannula	Heartport, Inc.	DWF	Class II	1999-04-20
K990972	Hp Viridia Component Monitoring System, Hp Viridia Cms 24/26, Hp Viridia Multi-Measurement Server and Compact Portable T	Hewlett-Packard Co.	DSI	Class II	1999-04-19
K990439	Careside Ck	Careside, Inc.	JHS	Class II	1999-04-19