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 2026-11-02, 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 2502 of 3531

510(k) clearances, page 2502 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903364	Gerard Medical, Inc. Trim-Port	Gerard Medical Enterprises, Inc.	LJT	Class II	1990-10-31
K903054	Hme-10 (Tm)	Pharma Systems AB	BYD	Class I	1990-10-31
K902846	Prizm Hearing System	Audioscience, Inc.	ESD	Class I	1990-10-31
K902683	Scopescrubber(tm)	Healthtek Microsurgical, Inc.	EOB	Class II	1990-10-31
K902478	Lifepak 300 Automatic Advisory Defibrillator	Physio Control, Inc.	LDD	Class II	1990-10-31
K902255	Omron Pulse Stimulator Model Hv-F05	Omron Electronics, Inc.	IPF	Class II	1990-10-31
K902191	Customed Lap Pack II	Customed, Inc	KKX	Class II	1990-10-31
K901923	Invotec Poly-Mesh Mandibular Tray	Invotec International, Inc.	JAZ	Class II	1990-10-31
K901705	Customed Cysto Pack II	Customed, Inc	KKX	Class II	1990-10-31
K900217	Bard Microbore Anti-Siphon Nitro Set	C.R. Bard Inc	FRN	Class II	1990-10-31
K900094	Pe-Mt 5 Medi-Tech Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	1990-10-31
K904598	Accu Path Sterile Label	Accu-Path	LDQ		1990-10-30
K904578	Modification Auto Suture(r) Endoscopic Clamp	United States Surgical, A Division of Tyco Healthc	GET	Class I	1990-10-30
K904126	Visiraser	Acorn Group, Inc.	GEX	Class II	1990-10-30
K904113	Operative Recording Camera	Medical Dynamics, Inc.	IKO	Class II	1990-10-30
K904112	Sti Drape Sheet Style 1908	Sterilizer Technologies Corp.	KKX	Class II	1990-10-30
K903947	Qualtex Needle Counters	DeRoyal Industries, Inc.	MMK	Class II	1990-10-30
K903636	Osteonics Drm Acetabular Component	Osteonics Corp.	JDI	Class II	1990-10-30
K902778	Surgical Dynamics Nucleotome II Tissue Aspir/cuter	Surgical Dynamics Ltd	HRX	Class II	1990-10-30
K902149	Fresenius/delmed 90/2 Peritoneal Dialysis System	Fresenius/Delmed, Inc.	FKX	Class II	1990-10-30
K902056	Laser Trap 100 Laser Plume Smoke Evacuation Filter	Hollister, Inc.	JDY	Class I	1990-10-30
K904637	Qbc(r) Centrifugal Hematology Control/multiple	R & D Systems, Inc.	JPK	Class II	1990-10-29
K904498	Cromatest Rheumatoid Diagnostic/rf Latex Test	Biotrax, Inc.	DHR	Class II	1990-10-29
K904226	'Tdxflx Analyzer	Abbott Medical	LCQ	Class II	1990-10-29
K903857	Non-Sterile Latex Dental Procedure Gloves	Formtex Medical Sdn. Bhd.	LYY	Class I	1990-10-29
K903622	CT Guide (Tm)	Radi Medical Systems AB	JAK	Class II	1990-10-29
K903445	Olympic Bili-Meter(tm) with Type-F Sensor	Olympic Medical Corp.	LBI	Class II	1990-10-29
K903030	Sophycamera Dsm 315	Provino	IYX	Class I	1990-10-29
K902989	G.e. Monitrol 90 and G.e. Monitrol 15	Electromek Diagnostic Systems, Inc.	IXR	Class II	1990-10-29
K902791	G.e. 48-4 Ceiling Tubehanger	Electromek Diagnostic Systems, Inc.	KPR	Class II	1990-10-29
K902079	Admixture Container for Total Parenteral Nutrition	Chartermed, Inc.	KPE	Class II	1990-10-29
K901566	Promatron 3000	Promatek Medical Systems, Inc.	IKK	Class II	1990-10-29
K896375	Preemicare Nebutech Nebulizer System	Preemicare Corp.	CAF	Class II	1990-10-29
K904740	Ampro Latex Exam Glove	American Pro Latex, Inc.	LYY	Class I	1990-10-26
K904720	Powercut Surgical System, Blades, and Accessories	Baxter Healthcare Corporation	HRX	Class II	1990-10-26
K904585	Post Mydriatic Spectacles	Yorktowne Optical Co., Inc.	HQY	Class I	1990-10-26
K904540	Video System Interface Models	Perkins Mfg. Co.	IZI	Class II	1990-10-26
K904484	Baxter Single Patient Use Pressure Infusor	Tecnadyne Scientific, Inc.	KZD	Class I	1990-10-26
K904461	Meter Trax	Hematronix, Inc.	JPK	Class II	1990-10-26
K904405	Bioclones Elegance Fsh Elisa Kit	Bioclone Australia Pty, Ltd.	CGJ	Class I	1990-10-26
K904304	Dupont Dimension(r) Tobramllycin(tobr) Method	E.I. Dupont de Nemours & Co., Inc.	KLB	Class II	1990-10-26
K904303	Dupont Drug Clibrator-B	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1990-10-26
K904274	Receiving Blanket	Anago, Inc.	KME	Class I	1990-10-26
K904223	Sepacell(r) R-200/500 Leukocyte Removal Recip Sets	Baxter Healthcare Corporation	CAK	Class II	1990-10-26
K904221	Sepacell(r) Pl-5A/10a Leukocyte Removal Filters	Baxter Healthcare Corporation	CAK	Class II	1990-10-26
K904099	Uric Acid/iron/magnesium Linearity Standards	Hichem Diagnostics	JJY	Class I	1990-10-26
K904087	Mobilaire III and V Model Irc 301 and 501 Oxy. Con	Invacare GmbH	CAW	Class II	1990-10-26
K903936	Slt Contact Laser System Nd:yag Medical Laser Syst	Surgical Laser Technologies, Inc.	GEX	Class II	1990-10-26
K903910	Lubricating Jelly	Lake Pharmaceutical, Inc.	KMJ	Class I	1990-10-26
K903909	Blind Controls for Drugs of Abuse Testing	Rapid Diagnostic Laboratories, Inc.	DIF	Class I	1990-10-26