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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3016 of 3529

510(k) clearances, page 3016 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844372	Hand Controlled Electrosurgical Pencil Disposable	Consolidated Medical Equipment Company	GEI	Class II	1985-02-21
K844337	X-Ray Tubestands Bucky Stands & Veterinary X-Ray	Quality X-Ray Manufacturing, Inc.	IYB	Class I	1985-02-21
K844010	Cpnogard Capnometer 1250	Novametrix Medical Systems, Inc.	CCK	Class II	1985-02-21
K843988	S.e.t. Tube	Bfw Laboratories, Inc.	BTR	Class II	1985-02-21
K843876	Leukoflex Surgical Tape	Beiersdorf, Inc.	KGX	Class I	1985-02-21
K843875	Leukosilk	Beiersdorf, Inc.	KGX	Class I	1985-02-21
K843874	Leukopor Surgical Tape	Beiersdorf, Inc.	KGX	Class I	1985-02-21
K843873	Leukofix R	Beiersdorf, Inc.	KGX	Class I	1985-02-21
K844856	Me20 Tracerite Clear Vent Tape, Me30 Tracerite Non	Bristol Medical Electronics Corp.	DRX	Class II	1985-02-20
K844631	Periflux Pf-2	Medex, Inc.	DPW	Class II	1985-02-20
K844428	Radiotom 804	Siemens Medical Solutions USA, Inc.	GEI	Class II	1985-02-20
K844403	Model Force 2 Electrosurgical Generator	Medtronic, Inc.	GEI	Class II	1985-02-20
K844371	Hand Controlled Electrosurgical Pencil-Reuseable	Consolidated Medical Equipment Company	GEI	Class II	1985-02-20
K844220	Aries Medical Perflex Percutaneous 40Cc D/l Balloo	Aries Medical, Inc.	DSP	Class II	1985-02-20
K850564	Clinic Electronic Thermometer	Gemini Electronics Co., Ltd.	FLL	Class II	1985-02-19
K844706	Tricon Revision Total Knee System	Richards Medical Co., Inc.	HSX	Class II	1985-02-19
K844635	Hydroset Root Canal Sealer	Lund Manufacturing Co.	KIF	Class II	1985-02-19
K844487	Mecron Femoral Head W/cone as Unipolar or Bipolar	Mecron Medical Products, Inc.	KWL	Class II	1985-02-19
K844486	Mecron Mrc-Headless Femoral Component	Mecron Medical Products, Inc.	KWL	Class II	1985-02-19
K844482	Muller Titanium Backed Acetabular Cup Component	Advanced Biosearch Assn.	JDL	Class III	1985-02-19
K844368	Linear Lift Device	Cybex	IKK	Class II	1985-02-19
K843612	Modification of Abl Mic-10 Precept Sys	Austin Biological Laboratories	LTD	Class III	1985-02-19
K842133	Eyrthrocath Double-Lumen Central Venous	Cardio Search, Inc.	FOZ	Class II	1985-02-19
K833528	Carbon Dioxide Laser Ml 825	Merrimack Laboratories	HHR	Class II	1985-02-19
K850432	Laser Benign & Malignant Pulmonary Obstructions-	Cooper Lasersonics, Inc.	LLO	Class II	1985-02-15
K850369	Quinton White Sealing Cap	Quinton, Inc.	FOZ	Class II	1985-02-15
K850363	Pollenex Digital Thermometer T-225	Associated Mills, Inc.	FLL	Class II	1985-02-15
K850362	Pollenex Digital Thermometer T-125	Associated Mills, Inc.	FLL	Class II	1985-02-15
K844971	Monocular Direct Ophthalmoscope	Nidek, Inc.	HLI	Class II	1985-02-15
K844949	Syva Sample Seal	Syva Co.	KIE	Class I	1985-02-15
K844750	Fresenius A2008 Hemodialysis Machine Expansion Mod	Seratronics, Inc.	FKQ	Class II	1985-02-15
K844277	Omikron Pacemaker 837 Unipolar & 838 Bipolar	Omikron Scientific, Ltd.	DXG	Class II	1985-02-15
K844077	Nutrimix Empty Container	Abbott Medical	KPE	Class II	1985-02-15
K844043	Ovudate	Joel R.L. Ehren Kranz	LHD	Unclassified	1985-02-15
K844013	Care Electric Breast Pump	Hankscraft Div. of Gerber Products Co.	HGX	Class II	1985-02-15
K843597	Nidek Monocular Indirect Ophthalmoscope	Nidek, Inc.	HLI	Class II	1985-02-15
K843596	Nidek-Binocular Indirect Ophthalmoscope	Nidek, Inc.	HLI	Class II	1985-02-15
K841374	Home Pro Volumetric Infusion Pump	American Edwards Laboratories	FRN	Class II	1985-02-15
K840204	White Ocular Pressure Relief Device	Precision-Cosmet Co., Inc.	KYF	Class II	1985-02-15
K850437	Disposable Laryngoscope	Vital Signs, Inc.	LLW	Class II	1985-02-14
K850309	Comfit Plus Endotracheal Tube Holder & Bite Block	Ackrad Laboratories	JAY	Class I	1985-02-14
K850247	Peritoneal Dialysis Coil Catheter	Sil-Med Corp.	FXX	Class II	1985-02-14
K850170	Heart Aid Model 97	Cardiac Resucitator Corp.	DRO	Class II	1985-02-14
K850154	Dignity Pant & Absorbent Pads	Convatec, A Division of E.R. Squibb & Sons	EYQ	Class I	1985-02-14
K850153	Adult Dispos. Incontinent Pants	Convatec, A Division of E.R. Squibb & Sons	EYQ	Class I	1985-02-14
K850134	Entron Enteral Feeding Bag	Biosearch Medical Products, Inc.	KNT	Class II	1985-02-14
K850074	Esophogeal Ph Catheter	Biosearch Medical Products, Inc.	FFT	Class I	1985-02-14
K850045	Spirometrics 2453 & Smi III	Spirometrics, Inc.	BTY	Class II	1985-02-14
K844956	Ava-Mist Portable Air Compressor	Avatron, Inc.	BTI	Class II	1985-02-14
K844940	Spacelabs Model 90201 Holter Recorder	Spacelabs, Inc.	DSH	Class II	1985-02-14