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 2248 of 3531

510(k) clearances, page 2248 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935289	Pro Fit-Cyber II Option	Qualitone	ESD	Class I	1993-12-22
K935229	Opus Digitoxin	Pb Diagnostic Systems, Inc.	DPG	Class II	1993-12-22
K935059	Insufflation Tubing Set, Phx500-082	Phx Technologies Corp.	FCX	Class II	1993-12-22
K934839	Mesalt Sterile Dressing	Richard Hamer Assoc., Inc.	KMF	Class I	1993-12-22
K934163	Watts Rake Device	Phx Technologies Corp.	GCJ	Class II	1993-12-22
K934048	Gh Gloves (Powder Free)	Grafik Hersteller Sdn Bhd	LYY	Class I	1993-12-22
K934047	Gh Gloves (Powered)	Grafik Hersteller Sdn Bhd	LYY	Class I	1993-12-22
K933308	Dynarex Gauze Sponge or Pads	Dynarex Corp.	EFQ	Unclassified	1993-12-22
K932978	Calssique or Mystique	Dekumed, Kunststofftechnik Degler GmbH	KCZ	Class I	1993-12-22
K932665	Encore Powder-Free Surgical Gloves Microptic	Smith & Nephew Perry	KGO	Class I	1993-12-22
K932664	Encore Powder-Free Surgical Gloves Orthopaedia	Smith & Nephew Perry	KGO	Class I	1993-12-22
K932591	Endo-Judge	Synergistic Medical Technologies, Inc.	GAB	Class I	1993-12-22
K931195	Percutaneous Drainage Loop Catheter Set	Cook Incorporated	KOD	Class II	1993-12-22
K930860	Hepa 2500 Air Cleaner	Trion, Inc.	FRF	Class II	1993-12-22
K930702	Dryslide Cefin	Difco Laboratories, Inc.	JTN	Class II	1993-12-22
K930632	Chemosite Implantable Drug Delivery	Device Labs, Inc.	KMF	Class I	1993-12-22
K926586	Revised Labeling for Chromic and Plain Gut Sutures	Look, Inc.	GAL	Class II	1993-12-22
K926132	Royal Shield Shield Gloves	Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.	LYY	Class I	1993-12-22
K924906	Powder-Free Latex Examination Gloves	Jentera Jaya Sdn Bhd	LYY	Class I	1993-12-22
K934859	Contact Lenses	Arno Intl., Inc.	HPC	Class I	1993-12-21
K934331	Thayer Martin, Modified Pill Pocket	Hardy Diagnostics	JTY	Class II	1993-12-21
K934053	Quanta Lite(tm) Histone Elisa	Inova Diagnostics, Inc.	LLL	Class II	1993-12-21
K933992	Olympus Sclerotherapy Balloon	Olympus Corp.	KNQ	Class II	1993-12-21
K933323	Russell & Hancock 524 and 422 Sunglasses	Russell & Hancock, Ltd.	HQY	Class I	1993-12-21
K933091	Stage IV, Cm-4000,Mattress Overlay System	Creative Medical Inc.	FNM	Class II	1993-12-21
K932800	Cardima Tracker(r) Infusion Catheter	Cardima, Inc.	KRA	Class II	1993-12-21
K931658	In-Line Burette Set	Douglas Medical Products, Inc	FPA	Class II	1993-12-21
K931594	Thera-Turn Cm-1000 Mattress Overlay System	Medical Device Inspection Company	IOQ	Class II	1993-12-21
K931430	Cutaneous Electrode	Medicotest, Inc.	GXY	Class II	1993-12-21
K931426	Nf-11-E Disposable Reference/recording Electrode	Medicotest, Inc.	GXY	Class II	1993-12-21
K931009	Tyshak Peripheral Balloon Dilation Catheter	Numed Inc	LIT	Class II	1993-12-21
K933834	Aesculap Rigid Endoscopes	Aesculap Inc	GCJ	Class II	1993-12-20
K935578	Urine Meter	Puritas Health Care, Inc.	EXR	Class II	1993-12-17
K935179	Emds Albumin (Alb) Test	Em Diagnostic Systems, Inc.	CIX	Class II	1993-12-17
K935178	Emds Phosphorous (Phos) Test	Em Diagnostic Systems, Inc.	CEO	Class I	1993-12-17
K934803	Arterial & Venous Blood Tubing Sets for Hemodialysis	Baxter Healthcare Corporation	FJK	Class II	1993-12-17
K934642	I-Stat Ionized Calcium Test	I-Stat Corp.	JFP	Class II	1993-12-17
K934330	Transgrow	Hardy Diagnostics	JTY	Class II	1993-12-17
K934078	Phx Technologies Corp.,10mm Sterile, Disposable Pool Tip Suction Cannula	Phx Technologies Corp.	GCJ	Class II	1993-12-17
K934027	Phx Technologies Corp., Alligator Grasper Device	Phx Technologies Corp.	GCJ	Class II	1993-12-17
K934026	Phx Technologies Corp. Bowel Grasper Device	Phx Technologies Corp.	GCJ	Class II	1993-12-17
K934025	Phx Technologies Corp, Sponge Grasper Device	Phx Technologies Corp.	GCJ	Class II	1993-12-17
K934024	Phx Technologies Corp., Suture Grasper Device	Phx Technologies Corp.	GCJ	Class II	1993-12-17
K934023	Phx Technologies Corp., Altraumatic Grasper Device	Phx Technologies Corp.	GCJ	Class II	1993-12-17
K934022	Phx Tech Single Action Heavy-Tooth Jaw Claw Grasper	Phx Technologies Corp.	GCJ	Class II	1993-12-17
K934021	Phx Technologies Corp., Bowel Grasper Device	Phx Technologies Corp.	GCJ	Class II	1993-12-17
K933691	Sigma CO2 Alkaline Buffer Reagent	Sigma Chemical Co.	JFL	Class II	1993-12-17
K933679	Sigma Bun Reagent	Sigma Chemical Co.	LFP	Class II	1993-12-17
K932278	Pfm Professional 7000 Spirometer	Advanced Medical Systems, Inc.	BTY	Class II	1993-12-17
K931661	Ultrabronz Series 800 (Eclipse) Tanning Bed	Eurocut, Ltd.	LEJ	Class II	1993-12-17