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 2547 of 3530

510(k) clearances, page 2547 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K900543	Chlamydiazyme Diagnostic Kit	Abbott Medical	LJC	Class I	1990-05-03
K900539	Model Dlase 300 Nd:yag Laser System: Intraoral	Sunrise Technologies, Inc.	GEX	Class II	1990-05-03
K900529	Model 9018 Pc Sunglasses W/polycarbonate Lenses	J & B Assoc.	HQY	Class I	1990-05-03
K900528	Model 8806 Sd Sunglasses W/acrylic Lenses	J & B Assoc.	HQY	Class I	1990-05-03
K900527	Model S139029 Sunglasses W/mirror Acrylic Lenses	J & B Assoc.	HQY	Class I	1990-05-03
K900526	Model F 1 Flip-Up Sunglasses W/polorized Lens	J & B Assoc.	HQY	Class I	1990-05-03
K900524	Model F3 Flip Up Sunglasses W/polorized Computer	J & B Assoc.	HQY	Class I	1990-05-03
K900522	Model N741 Sunglasses W/acrylic Blue Computer Lens	J & B Assoc.	HQY	Class I	1990-05-03
K900521	Model N742 Sunglasses W/polycarbonate Blue Blocker	J & B Assoc.	HQY	Class I	1990-05-03
K900520	Model N742 Sunglasses W/acrylic Night Driver Lens	J & B Assoc.	HQY	Class I	1990-05-03
K896919	Heartstart 3000	Laerdal Medical a/S	MKJ	Class III	1990-05-03
K896575	Dantec Menuet	Dantec Medical, Inc.	FAP	Class II	1990-05-03
K894515	Liss Cranial Stimulator Model Sbl201-M	Medical Consultants Intl., Ltd.	QJQ	Class II	1990-05-03
K901807	Olympus Inorganic Phosphorus (2-Reagent Modifica.)	Em Diagnostic Systems, Inc.	CEO	Class I	1990-05-02
K901759	Cobas-Fp Reagents for Vancomycin	Roche Diagnostic Systems, Inc.	LEH	Class II	1990-05-02
K901750	Latex Patient Examination Gloves	Haikou Latex Factory	LYY	Class I	1990-05-02
K901674	Aia-600 Automated Enzyme Immunoassay System	Tosoh Corp.	KHO	Class I	1990-05-02
K901596	Nova Lite(tm) Ana Ksl	Inova Diagnostics, Inc.	DHN	Class II	1990-05-02
K901575	Reusable TENS Paravertebral Pad #641 Back Electrod	Pioneering Technologies, Inc.	GXY	Class II	1990-05-02
K901533	Gdc 588 Casting Alloy	The J.M. Co.	EJT	Class II	1990-05-02
K901532	Gdc 3084 Casting Alloy	Deringer-Ney, Inc.	EJT	Class II	1990-05-02
K901486	Weinstein Style Instrument Holder	David Ayres Medical Co.	LDQ		1990-05-02
K901325	Thromboplastin.c Plus	Baxter Healthcare Corporation	GJS	Class II	1990-05-02
K901297	Exactech Porous Coat Total Hip Prost Fem Stem Comp	Exactech, Inc.	JDI	Class II	1990-05-02
K901270	Lyphochek Urine Toxicology Control - Screen	Bio-Rad	DIF	Class I	1990-05-02
K900892	Microdelta, Gated Single Photon (Spect) Package	Siemens Gammasonics, Inc.	KPS	Class II	1990-05-02
K900852	Magnet Retrieval Catheter	Cook Inc.	KNT	Class II	1990-05-02
K900827	Colorimetric Chloride Product #4314125	American Research Products Co.	CHI	Class I	1990-05-02
K900796	Cmv Igg Elisa Test	Gull Laboratories, Inc.	LFZ	Class II	1990-05-02
K900735	Model 130 Automatic Height Adjust (Aha) Incubator	Preemicare Corp.	FMZ	Class II	1990-05-02
K900572	Lyme Igm Microassay	Diamedix Corp.	LSR	Class II	1990-05-02
K900559	Response External Penile Rigidity Device	Smith-Collins Pharmaceutical, Inc.	LKY	Class II	1990-05-02
K900555	Interson Multiplane Rectal Probe for Aloka Ultra.	Interson Corp.	ITX	Class II	1990-05-02
K900485	Enzymun Test(r) Cortisol	Boehringer Mannheim Corp.	CGR	Class II	1990-05-02
K900196	Lyme Igm Elisa Test System	Zeus Scientific LLC	LSR	Class II	1990-05-02
K900110	Operand* Lubricating Jelly	General Medical Co.	KMJ	Class I	1990-05-02
K897078	Accuprobe Mycobacterium Avium Complex Culture	Hologic, Inc.	LQF	Class I	1990-05-02
K896853	Precision Osteolock Femoral Comp. Titanium Plasma	Howmedica Corp.	KWL	Class II	1990-05-02
K896695	Dyna-Flo Urinary Drainage Bag	MEDLINE INDUSTRIES, LP - Northfield	EYZ	Class I	1990-05-02
K896688	Urine Collector Leg Bag	MEDLINE INDUSTRIES, LP - Northfield	KNX	Class II	1990-05-02
K896544	Md2 Personal Infusion System	Norfolk Medical Products, Inc.	FRN	Class II	1990-05-02
K895933	Enteral Pump Sets for Use with Ross Flexiflo-III	Delmed, Inc.	KNT	Class II	1990-05-02
K895919	Enteral Bag Admini. Sets for Use W/flexiflo-III	Delmed, Inc.	KNT	Class II	1990-05-02
K895696	Enteral Pump Set W/enteral Spike for Use W/feed Pu	Delmed, Inc.	KNT	Class II	1990-05-02
K895366	Enteral Pump Set with Entera (Tm)-Flo Spike	Fresenius USA, Inc.	KNT	Class II	1990-05-02
K895330	600Ml and 1200Ml Enteral Bag Adm. Set for Frenta	Delmed, Inc.	KNT	Class II	1990-05-02
K895246	Frenta(r) Duo-Set	Delmed, Inc.	KNT	Class II	1990-05-02
K901778	3M Heat Comfort Portable Self-Heating Pad	3M Company	IMD	Class I	1990-05-01
K901662	Anatomical Malar Implant	Implantech Associates Inc	LZK	Class II	1990-05-01
K901484	Lumatag(tm) Hcg Chemiluminescence Immunometric	London Diagnostics, Inc.	JHI	Class II	1990-05-01