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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3510 of 3526

510(k) clearances, page 3510 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760758	Sterilization Packaging Materials	Paper Manufacturers Co.	FRG	Class II	1976-12-02
K760710	Pulsar Pulse Monitor Watch	Time Computer, Inc. (Tci)	DRT	Class II	1976-12-02
K760679	4-Way Stopcock W/7cm Tubing,	American Viggo	FMG	Class II	1976-12-02
K760678	4-Way Stopcock W/100 Cm Tubing, Luer-Lk	American Viggo	FMG	Class II	1976-12-02
K760667	4-Way Stopcock W/10 Cm Exten. Tubing	American Viggo	FMG	Class II	1976-12-02
K760666	4-Way Stopcock W/luer-Lock Fitting	American Viggo	FMG	Class II	1976-12-02
K760661	Sterilizer Wrap (Cat#221831,2,3,4,5,6)	C.R. Bard Inc	FRG	Class II	1976-12-02
K760189	Stopcock, Waterline	V. Mueller O.V. Baxter Healthcare Corp.	FAJ	Class II	1976-12-02
K760184	Element, Working	V. Mueller O.V. Baxter Healthcare Corp.	FDC	Class II	1976-12-02
K760183	Obturator, Deflecting	V. Mueller O.V. Baxter Healthcare Corp.	FEC	Class II	1976-12-02
K760182	Sheath, Resectoscope	V. Mueller O.V. Baxter Healthcare Corp.	FDC	Class II	1976-12-02
K760180	Forceps, Grasping	V. Mueller O.V. Baxter Healthcare Corp.	OCZ	Class II	1976-12-02
K760179	Sheath, Cystourethroscope W/ Obturator	V. Mueller O.V. Baxter Healthcare Corp.	FAJ	Class II	1976-12-02
K760173	Bridge, Short Deflecting	V. Mueller O.V. Baxter Healthcare Corp.	FAM	Class II	1976-12-02
K760172	Obturator, Visual	V. Mueller O.V. Baxter Healthcare Corp.	FEC	Class II	1976-12-02
K761097	Vanderbilt Blade Holder	Cerenovus, Inc.	HAO	Class I	1976-11-30
K761096	Vanderbilt Pituitary Retractor	Cerenovus, Inc.	GAD	Class I	1976-11-30
K761095	Vanderbilt Curette	Cerenovus, Inc.	HAO	Class I	1976-11-30
K761067	Dentsply Die Stone	Ransom & Randolph. LLC.			1976-11-30
K761053	Anodyne II-Electrical Neuro Stimulator	Rich-Mar Corp.	GZJ	Class II	1976-11-30
K761029	Auto-Calcium Reag for Gilford 3400E Anal	Harleco	CJY	Class II	1976-11-30
K761028	Auto-Albumin Reag for Abbott Aba-100	Harleco	CIX	Class II	1976-11-30
K761027	Auto-Total Bilirubin Reag for Gilford an	Harleco	CIG	Class II	1976-11-30
K761026	Auto-Albumin Reag for Gilford 3400E Anal	Harleco Diagnostics	CIX	Class II	1976-11-30
K760769	Temperature Regulated Five Cell Holders	Revvity Health Sciences, Inc.	JRI	Class I	1976-11-30
K760761	Esophageal Motility Tube	Sherwood Medical Industries	FFX	Class II	1976-11-30
K760720	Mon-a-Therm Temparature Monitor Sys	Labarge, Inc.	FLL	Class II	1976-11-30
K760711	Reagent System (No. Sc 135)	Sigma Chemical Co.	JPZ	Class I	1976-11-30
K760713	Triglycerides Test	Boehringer Mannheim Corp.	CDT	Class I	1976-11-29
K761033	Computerized Tomography Scanner	Syntex Corp.	JAK	Class II	1976-11-24
K761025	Bag Resuscitator	Robert Shaw Controls Co.	BTM	Class II	1976-11-24
K761022	Xeroradiography 125 System - Modified	Xeroradiography	IXK	Class II	1976-11-24
K760799	Fluocal Gel Orange	Septodont			1976-11-24
K760798	Fluocal Gel Mint	Septodont			1976-11-24
K760737	Scattered Transmission Accessory	Revvity Health Sciences, Inc.	JJQ	Class I	1976-11-24
K760712	Mediscus Air Bed	Hsi Products, Inc.	INX	Class II	1976-11-24
K760685	Sigma Proced #Sc165	Sigma Chemical Co.	CJE	Class II	1976-11-24
K760634	Aca Phosphorus Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	CEO	Class I	1976-11-24
K760622	Lancer Autoanalyzer Manifold Pump Tub	Sherwood Medical Industries	JJC	Class I	1976-11-24
K760618	Patient Restraint	Encompass Group LLC	FMQ	Class I	1976-11-24
K760594	Auto-Fi Coagulation Instrument	Dade, Baxter Travenol Diagnostics, Inc.	JPA	Class II	1976-11-24
K761021	Ankle Instruments (Freeman-Swanson)	Medishield, Inc.	HSN	Class II	1976-11-23
K761020	Ankle (Freeman-Swanson)	Medishield, Inc.	HSN	Class II	1976-11-23
K761003	Charnley Congenital Hip Femur (85-3061)	Cerenovus, Inc.	JDG	Class II	1976-11-23
K761002	Charnley Congenital Hip Femur (85-3060)	Cerenovus, Inc.	JDG	Class II	1976-11-23
K760970	Florio Cpc Band	Richard'S Medical Equip., Inc.	HWN	Class I	1976-11-23
K760945	Silastic Percutaneous Gastrointest. Tube	Dow Corning Corp. Healthcare Industries Materials	KNT	Class II	1976-11-23
K760943	Silastic Brand Gastric Lavage Tube	Dow Corning Corp. Healthcare Industries Materials	KNY	Class II	1976-11-23
K760914	Double Elutra-Pack Unit	Travenol Laboratories, S.A.	KSW	Class II	1976-11-23
K760860	Silastic Ileal Reservoir Catheter	Dow Corning Corp. Healthcare Industries Materials	EXB	Class I	1976-11-23