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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2679 of 3530

510(k) clearances, page 2679 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884948	Model 3587A Resume Epidural Lead	Medtronic, Inc.	GZB	Class II	1989-01-17
K884769	Model 654 a Sodium, Potassium & Lithium Ise Analy	Ciba Corning Diagnostics Corp.	CEM	Class II	1989-01-17
K884730	Shiley Perc Tracheostomy System	Shiley, Inc.	BTO	Class II	1989-01-17
K884708	Fiagen Hfsh Time-Resolved Fluoroimmunoassay Kit	Cyberfluor, Inc.	CGJ	Class I	1989-01-17
K884707	Fiagen Digoxin Time-Resolved Fluoroimmunoassay Kit	Cyberfluor, Inc.	LCS	Class II	1989-01-17
K884678	Esp 3-Phase X-Ray Generators	Elscint, Inc.	IZO	Class I	1989-01-17
K884663	Impulse Epidural Electrode	Impulse Systems, Inc.	JXE	Class II	1989-01-17
K884539	Holter 24-Hour ECG Playback, Model 150	Rmv Medical (Romavat, Inc.)	DSI	Class II	1989-01-17
K884520	Servo Ventilator 900E	Siemens-Elema Ventilation Systems	CBK	Class II	1989-01-17
K884490	Introducer Safety Syringe	Arrow Intl., Inc.	DQX	Class II	1989-01-17
K884484	Magnetic Resonance Diagnostic Helmholtz Neck Coil	Siemens Medical Solutions USA, Inc.	LNH	Class II	1989-01-17
K884440	Tecnol Variable Tension Bandage	Tecnol New Jersey Wound Care, Inc.	NAD	Class I	1989-01-17
K884398	Omnifit Total Knee Series II Tibial Inserts	Osteonics Corp.	JWH	Class II	1989-01-17
K884158	The System, Sara Digicap Plus Ohmeda Minx Oximeter	Ppg Industries, Inc.	CCK	Class II	1989-01-17
K884135	Dm100 (Distal Monitor - 100)	Bio.Logic, Inc.	HCC	Class II	1989-01-17
K883743	Medtronic Model 4058 Pacing Lead	Medtronic, Inc.	DTB	Class III	1989-01-17
K883440	E550 Electrocardiograph	Burdick Corp.	DSI	Class II	1989-01-17
K883402	Excalibur Controller (Work Load Programmer)	Quinton, Inc.	DPS	Class II	1989-01-17
K883214	Thoracic Support System	Storer Medical Products	KMO	Class I	1989-01-17
K883109	Minimon 7136B Patient Monitor	Kontron, Inc.	DRT	Class II	1989-01-17
K883069	Minimon 7134B Patient Monitor	Kontron Instruments, Inc.	DRT	Class II	1989-01-17
K882825	Takeda Medical Auto. Dig. Blood Pres. Meter W/prin	A and D Engineering, Inc.	DXN	Class II	1989-01-17
K882824	Takeda Medical Auto. Digital Blood Pres. Monitor	A and D Engineering, Inc.	DXN	Class II	1989-01-17
K881323	Curietron 192 Low Dose Rate	Compagnie Oris Industrie, S.A.	JAQ	Class II	1989-01-17
K890042	Microscope Slides Precoated	Stat Path	KEW	Class I	1989-01-13
K885252	Map Dc-Coupled Isolated Preamplifier Model #1001	Ep Technologies, Inc.	DRQ	Class II	1989-01-13
K885215	Lincoln Mills Hip Holder	Lincoln Mills, Inc.	FWZ	Class I	1989-01-13
K885200	600 & 900 Series Electrodes & 755 & 756 Handle	Olsen Electrosurgical, Inc.	GEI	Class II	1989-01-13
K885199	#500 Series Forceps W/cut/coagulate Switches	Olsen Electrosurgical, Inc.	GEI	Class II	1989-01-13
K885100	Mcconnell Reamer Guide	Mcconnell Orthopedic	HTO	Class I	1989-01-13
K885049	Rs-Cup Acetabular Prosthesis	Allo Pro Corp.	KWA	Class III	1989-01-13
K884988	Gamma Glutamyl Transferase Test (Ggt) Item: 65664	Em Diagnostic Systems, Inc.	JQB	Class I	1989-01-13
K884987	Urea Nitrogen Test (Bun) Item Number: Sr1022	Em Diagnostic Systems, Inc.	CDQ	Class II	1989-01-13
K884986	Calcium Test Item Number: Sr1009	Em Diagnostic Systems, Inc.	CIC	Class II	1989-01-13
K884911	Cortronic Scr1000	Cortronic Corp.	DSF	Class I	1989-01-13
K884900	Siemens Sector 3.5 and 5.0 Mhz Cda Transducer	Siemens Medical Solutions USA, Inc.	KNW	Class II	1989-01-13
K884880	Pregnagen(tm)	Biogenex Laboratories, Inc.	JHI	Class II	1989-01-13
K884756	Clinistat Glucose Reagent Test	Kulzer GmbH	CGA	Class II	1989-01-13
K884632	Acuson I5100 Ultrasound Transducer	Acuson Corp.	IYO	Class II	1989-01-13
K884616	Firstday Early Pregnancy Testing Kit II	Pacific Biotech, Inc.	JHI	Class II	1989-01-13
K884516	Fitc Murine Monoclonal Anti-Rsv Igg	Whittaker Bioproducts, Inc.	GQG	Class I	1989-01-13
K884421	Pre-Gaged Balanced Cuff W/sylgard Antimicro. Treat	Pymah Corp.	DXQ	Class II	1989-01-13
K883750	Ventralith I	Bio Pace Technology, Inc.	DXY	Class III	1989-01-13
K883727	Bucket Prosthesis Porp	Treace Medical, Inc.	ETB	Class II	1989-01-13
K883544	Lyme Fast Test	3M Company	LSR	Class II	1989-01-13
K883373	Steri-Oss Hydroxyapatite-Coated Dental Implant	Denar Corp.	DZE	Class II	1989-01-13
K882633	Ensoniq Sound Selector, Bte Digital Prog. Hrng Aid	Ensoniq Corp.	ESD	Class I	1989-01-13
K882344	Electr-Transblotter	The W.E.P. Co.	JJN	Class I	1989-01-13
K881314	Promo-Rist C.p.m.	Professional Motion, Inc.	BXB	Class I	1989-01-13
K885171	Modified Label Change to Model 5455 Surgical Cable	Andover Medical, Inc.	DRO	Class II	1989-01-12