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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1730 of 3533

510(k) clearances, page 1730 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K992443	Advanta Graft	Atrium Medical Corporation	DSY	Class II	1999-08-20
K992441	Advanta Graft	Atrium Medical Corporation	DYF	Class II	1999-08-20
K992361	Pall Surgiclear Laparoscopic Smoke Filtration System, Model Clsf1	Pall Medical	FYD	Class II	1999-08-20
K992158	Lactosorb Sheets	Zimmer GmbH	JEY	Class II	1999-08-20
K992132	Cholesite Test System	Gds Technology, LLC	CHH	Class I	1999-08-20
K991985	Cook High Volume Infusion Adapter Intravascular Administration Set	Cook Inc.	FPA	Class II	1999-08-20
K991932	Intravascular Administration Set	The Kipp Group	FPA	Class II	1999-08-20
K991909	Delton Fs with Fluoride Pit & Fissure Sealant	Dentsply Intl.	EBC	Class II	1999-08-20
K991830	Capsular Shrinkage Electrode	Linvatec Corporation	JOS	Class II	1999-08-20
K991570	Jobst Ready-to-Wear Arm Sleeves	Beiersdorf-Jobt, Inc.	DWL	Class II	1999-08-20
K991312	Soothe & Smooth Scar Care - Silicone Sheeting	Library Medical, Inc.	MDA	Class I	1999-08-20
K991083	Rlp Cholesterol Immunoseparation Assay	Otsuka Pharmaceutical Co., Ltd.	CHH	Class I	1999-08-20
K990236	Modification of Jelco,jelco-W and Jelco* Plus i.v. Catheters, Cathlon* i.v. Catheters, Optiva* i.v. Catheters, Protect	Johnson & Johnson Medical, Div. of Ethicon, Inc.	FOZ	Class II	1999-08-20
DEN990005	The 3Pm Egg Machine	3pm Co., Inc.	MYE	Class II	1999-08-20
K992541	Laparocam	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1999-08-19
K992508	Tsx Probe, Ocular Contact Probe;tsx Probe,ocular Contact Probe,sma	Instruments for Medicine and Diagnostics	GEX	Class II	1999-08-19
K992506	Mini 6800 Digital Mobile C-Arm	GE Dec Medical Systems	OXO	Class II	1999-08-19
K992490	B2c Hip System	Lepine Groupe SpA.	JDI	Class II	1999-08-19
K992413	Escort 100/300 Series B (Escort II) Patient Monitor	Medical Data Electronics	DRT	Class II	1999-08-19
K992324	Funnel Trocar	Patton Medical Corp.	GCJ	Class II	1999-08-19
K992313	Xl Tek Evoked Potential Headbox, Model Ep-16	Excel Tech., Ltd.	GWF	Class II	1999-08-19
K992149	Geiger Electrosurgical Handpiece Sheath, Model 405	Geiger Medical Technologies, Inc.	GEI	Class II	1999-08-19
K992086	Olympus Serum Protein Multicalibrator 2	OLYMPUS Corporation of the Americas	JIX	Class II	1999-08-19
K992081	Various Ansell Tradenames or Private Label	Suretex Prophylactics (India), Ltd.	HIS	Class II	1999-08-19
K992032	Acry Island Border Dressing, Models 2031, 2032, 2033	Acrymed, Inc.	KMF	Class I	1999-08-19
K991941	Ebi Xfix Dfs Rail System	Electro-Biology, Inc.	KTT	Class II	1999-08-19
K991892	Trustex Mint Flavored Condom in Green Color, Impulse Mint Flavored Condom in Green Color	Line One Laboratories	HIS	Class II	1999-08-19
K991828	Strep B Oia	Biostar, Inc.	GTY	Class I	1999-08-19
K991819	Magnatek 30	Magna Advanced Technologies, Inc.	DQA	Class II	1999-08-19
K991739	Corometrics 120 Series Maternal/fetal Monitor	General Electric Medical Systems Information Techn	HGM	Class II	1999-08-19
K991735	Mac Series Electrocardiographs Including Mac 5000, Mac Pc, Mac 6, Mac Vu, Mac 8 Electrocardiographs	General Electric Medical Systems Information Techn	LOS		1999-08-19
K991664	Ldl Cholesterol, Product No's, 124-01, Ch102-01	A.P. Total Care, Inc.	LBS	Class I	1999-08-19
K991119	Tilt/recliner for Power Wheelchairs, Model 2G	Invacare GmbH	ITI	Class II	1999-08-19
K990630	Sas Adeno Test	SA Scientific, Ltd	GOD	Class I	1999-08-19
K990230	Electro-Nerve Stimulator TENS, Model Lx	BioMedical Life Systems Inc.	GZJ	Class II	1999-08-19
K984338	Jostra Hl-20 Twin Pump	Jostra Bentley	DPW	Class II	1999-08-19
K983886	Pockit Hsv 2 Rapid Test	Diagnology, Ltd.	LGC	Class II	1999-08-19
K992500	Cantor & Silver 5X Prosthetic Tinted (Hioxifilcon a) Soft Daily Wear Contact Lens	Cantor & Silver, Ltd.	LPL	Class II	1999-08-18
K992446	Dailies (Nelfilcon a) One-Day	Ciba Vision Johns Creek Mfg.	MVN	Class II	1999-08-18
K992411	Escort II+ 400 Series (Escort Prism) Monitor	Medical Data Electronics	DRT	Class II	1999-08-18
K992391	Urosurge Spiralflo Ureteral Stent	Urosurge, Inc.	FAD	Class II	1999-08-18
K992327	Duteck Digital Clinical Thermometer	Duteck Industrial Co., Ltd.	FLL	Class II	1999-08-18
K992160	Nexus 2	Sybron Dental Specialties, Inc.	EMA	Class II	1999-08-18
K992118	Prodigy 4 Translucent Shades	Sybron Dental Specialties, Inc.	EBF	Class II	1999-08-18
K992114	Ksea Calcusplit	Karl Storz Endoscopy-America, Inc.	FFK	Class II	1999-08-18
K991875	K-L-W Intraoral Distractor	KLS-Martin L.P.	MQN	Class II	1999-08-18
K991772	Cutaneous (Disc) Electrode	Neuro Supplies, Inc.	GXY	Class II	1999-08-18
K991771	Digital Ring Electrde	Neuro Supplies, Inc.	GXY	Class II	1999-08-18
K991770	Cutaneous (Ground) Electrode	Neuro Supplies, Inc.	GXY	Class II	1999-08-18
K991769	Cutaneous (Bar) Electrode	Neuro Supplies, Inc.	GXY	Class II	1999-08-18