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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3089 of 3528

510(k) clearances, page 3089 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K840674	Sensibead Eia Ige Kit	Terumo Medical Corp.	DGC	Class II	1984-04-04
K840661	Paramax Acid Phosphatase Reagent	American Dade	CKB	Class II	1984-04-04
K840656	Enternal Y Extension Set Recorder	Halyard Health	KNT	Class II	1984-04-04
K840650	B-Neocept 30	Organon LLC	JHJ	Class II	1984-04-04
K840618	Liqui-Ura Chemistry Urine Controls	Biodiagnostic Intl	JJW	Class I	1984-04-04
K840606	Ektachem Clinical Chem. Slides	Eastman Kodak Company	CIG	Class II	1984-04-04
K840596	Quinidine Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	LBZ	Class II	1984-04-04
K840588	Amerlex Human Placental Lactogen	Amersham Corp.	JMF	Class II	1984-04-04
K840557	Reagents & Standards Il 501 Na/k	Shaban Mfg. Co.	JGS	Class II	1984-04-04
K840506	Haemophilus Influenzae Type B	Scientific Device Laboratory, Inc.	LSC	Class I	1984-04-04
K840502	Cats-Clinical Lab Computer Software-	Precision Technology, Inc.	JQP	Class I	1984-04-04
K840501	Acculab Supplies Chemical Analyzers	Precision Technology, Inc.	JJE	Class I	1984-04-04
K840473	Ventrezyme T4 Immunoassay T4	Vxr, Inc.	KLI	Class II	1984-04-04
K840379	Parathyroid Hormone Analysis Product	Nichols Institute Diagnostics	CEW	Class II	1984-04-04
K840200	Progress Selective Dhemistry Analyz	Kone Instruments, Inc.	JJF	Class I	1984-04-04
K834582	Detect Group a Strep Test	Difco Laboratories, Inc.	GTZ	Class I	1984-04-04
K834526	Mast Inhalant Profile	Mast Immunosystems	DHB	Class II	1984-04-04
K834410	Double-Coagulation Switchpen 757	Olsen Electro-Surgical Instruments, Inc.	GEI	Class II	1984-04-04
K834329	Olsen 756 Rocker Switchpen	Olsen Electro-Surgical Instruments, Inc.	GEI	Class II	1984-04-04
K834292	Pall Heat Moisture Exchanging Filter	Pall Biomedical Products Co.	BYD	Class I	1984-04-04
K834241	Ana Applelisa	Apple Diagnostic Products	DHN	Class II	1984-04-04
K834171	Op-Con Surg. Instrument #3	Imm Enterprises, Ltd.	KOA	Class I	1984-04-04
K834048	Bovie Conductive Adhes-Disper-Electro	Castle Co.	GEI	Class II	1984-04-04
K833946	Epilot 80 S Tm	Leo Unlimited, Inc.	KCW	Class I	1984-04-04
K833934	Adrenocorticotropic Hormone Test	Clinetics Corp.	CKG	Class II	1984-04-04
K833176	Sdi Surgical Drape	Sdi	KKX	Class II	1984-04-04
K840709	Mid-Stream Urine Collection Sets	Concord Laboratories, Inc.			1984-04-03
K840165	Canal Aid	Qualitone	ESD	Class I	1984-04-03
K834593	One-Piece Shunt	American Heyer Schulte	JXG	Class II	1984-04-03
K840854	Medical Laser Endocoagulator 5K	Hgm, Inc.	HQF	Class II	1984-04-02
K840814	Hospal Model H1210	Hospal Medical Corp.	FKQ	Class II	1984-04-02
K840813	Biospal 1200S	Hospal Medical Corp.	FKQ	Class II	1984-04-02
K840812	Biospal 2400S	Hospal Medical Corp.	FKQ	Class II	1984-04-02
K840811	Biospal 3000S	Hospal Medical Corp.	FKQ	Class II	1984-04-02
K840711	Pulmonary Function Sys-3000	Med-Science Electronics, Inc.	BZC	Class II	1984-04-02
K840647	Amikacin Reagent Test Kit	Beckman Instruments, Inc.	LDN	Class II	1984-04-02
K840565	Monitor 5590- Analyzer 5595Ec	Hudson Oxygen Therapy Sales Co.	CCL	Class II	1984-04-02
K840537	Rast Allergo Sorbent Test	Pharmacia, Inc.	DHB	Class II	1984-04-02
K840269	Mc 2000 Ostomy Pouches	MEDLINE INDUSTRIES, LP - Northfield	EXB	Class I	1984-04-02
K840267	Filtroder Filters	MEDLINE INDUSTRIES, LP - Northfield	EXB	Class I	1984-04-02
K840265	Mc 2002 Ostomy Pouches & Skin Flanges	MEDLINE INDUSTRIES, LP - Northfield	EXB	Class I	1984-04-02
K834358	Parallel Dual Lumen Subclavian Cannula	Vas-Cath of Canada, Ltd.	FIQ	Class II	1984-04-02
K834347	Flexi-Flate Penile Implant	Surgitek	FAE	Class II	1984-04-02
K833782	Surgitek All Silicone Infection Doubj	Surgitek	FAD	Class II	1984-04-02
K833499	Fiberlas 100 Medical System	Fiberlase U.S.A.	LNK	Class II	1984-04-02
K833259	Multiple	Sun House Products Co.	HQG	Class I	1984-04-02
K840853	Immpulse Tbc Assay Reagents	Paragon Diagnostics, Inc.	KHQ	Class II	1984-04-01
K834445	Medi-Trace Quikset Dx Diag. Elect-	Graphic Controls Corp.	DRX	Class II	1984-04-01
K841158	Nebulo 28 Nebulizer Kit	Inspiron Corp.	BTT	Class II	1984-03-30
K841111	Rembrandt Shade Modification Kit	Den-Mat Corp.	EBF	Class II	1984-03-30