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 2026-10-26, 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 2728 of 3530

510(k) clearances, page 2728 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881969	Dry Comfort Disposable Underpad	Health Tec, Inc.	KME	Class I	1988-06-07
K881798	Technicon Chem 1(R) System, Direct Bilirubin	Technicon Instruments Corp.	CIG	Class II	1988-06-07
K881693	Terumo Sensibead Eia Progesterone Kit	Terumo Medical Corp.	JIS	Class II	1988-06-07
K881677	Bun (Kinetic)	Boehringer Mannheim Corp.	CDQ	Class II	1988-06-07
K881661	Ionoscem or Ionoscell Glass Ionomer Dental Cement	Specialites Septodont	EMA	Class II	1988-06-07
K881617	Indirect Immunofluorescent Antibody Assay	Granbio, Inc.	LSE	Class I	1988-06-07
K881417	Dahlberg Model Gp Body Aid	Dahlberg Electronics, Inc.	ESD	Class I	1988-06-07
K881261	Bion Hsv1-G or Hsv2-G Test System	Bion Ent., Ltd.	GQO	Class II	1988-06-07
K881216	Gent-L-Kare Vaginal Irrigation Set	Geneva Laboratories, Inc.	HED	Class I	1988-06-07
K881195	Dynatech Spd 2000, Number 002-910-0000	Dynatech Laboratories, Inc.	JQW	Class I	1988-06-07
K881173	Aspartate Aminotransferase (Colorimetric Method)	Tech-Co, Inc.	CIQ	Class II	1988-06-07
K881172	Bilirubin (Direct)	Tech-Co, Inc.	CIG	Class II	1988-06-07
K881099	Pe485r Fm Receiver Used W/pe481fst Fm Transmitter	Phonic Ear, Inc.	EPF	Class II	1988-06-07
K881019	Babyrocker	Cinventa AB	FMS	Class II	1988-06-07
K880654	Amresco Liquizyme Glucose/bun Standard 0124, 0200	American Research Products Co.	JIW	Class II	1988-06-07
K874902	Single Breath Lung Diffus Test Device Spirometery	Gomi Medical Instruments	BZM	Class II	1988-06-07
K882182	Salmonella-Shigella (Ss) Agar - Product #P3326	Lakewood Biochemical Co., Inc.	JSI	Class I	1988-06-06
K881933	Kallestad Quantafluor Antithyroid Antibody Test	Kallestad Diag, A Div. of Erbamont, Inc.	JZO	Class II	1988-06-06
K881926	Reusable Fiberoptic Lightpipe	Advanced Surgical Products, Inc.	HQB	Class II	1988-06-06
K881912	Sano Clip Appliers & Removers	Downs Surgical, Ltd.	HCI	Class II	1988-06-06
K881911	New Sizes Sugita Clips	Downs Surgical, Ltd.	HCI	Class II	1988-06-06
K881828	Immunoglobulin M Test System	The Binding Site	CFQ	Class II	1988-06-06
K881134	Slt Contact Laser System Oculoplastics	Surgical Laser Technologies, Inc.	HQF	Class II	1988-06-06
K880982	Oralix Pan Dc III Ceph or Panoramic Mode Only	Orion Corporation Soredex	KPR	Class II	1988-06-06
K880784	Wako(tm) Igg-Ha Direct	FUJIFILM Healthcare Americas Corporation	DEW	Class II	1988-06-06
K875260	Effner Cautery Instruments	Effner and Spreine Co.	HQP	Class II	1988-06-06
K873296	Dpx Bone Densitometer	Lunar Radiation Corp.	KGI	Class II	1988-06-06
K882070	Lumbar Impaction Set and Bone Graft Impactors	Karlin Technology, Inc.	KWP	Class II	1988-06-03
K882068	Cobb Spinal Elevators	Karlin Technology, Inc.	KWP	Class II	1988-06-03
K881962	Msi 2005 Series Bed	Med Service, Inc.	FNJ	Class I	1988-06-03
K881953	Sharplan Models 719/719Sr/719sl Colposlad Cos Su	Sharplan Lasers, Inc.	GEX	Class II	1988-06-03
K881952	Sharplan Models 719-O Colposlad CO2 Su Micromani.	Sharplan Lasers, Inc.	GEX	Class II	1988-06-03
K881859	Dripride Disposable Underpad	Weyerhaeuser Co.	KME	Class I	1988-06-03
K881845	Hare Any Level Cot	Dyna Industries, Inc.	FPO	Class II	1988-06-03
K881758	Viggo Vascuport Needle	GE Healthcare	FMI	Class II	1988-06-03
K881741	Stuart Lee Clip	Stuart-Lee, Inc.	GDJ	Class I	1988-06-03
K881673	Lima-Lto Ecs External Circular Stabilizer	Lima-Lto S.p.A.	JEC	Class II	1988-06-03
K881588	Model Md-25 Laser for Surgical Use	Laser Engineering, Inc.	GEX	Class II	1988-06-03
K881587	Model Md-25 CO2 Laser for Podiatry Applications	Laser Engineering, Inc.	GEX	Class II	1988-06-03
K881586	Model Md-45 CO2 Laser for ENT Applications	Laser Engineering, Inc.	GEX	Class II	1988-06-03
K881585	Model Md-25 CO2 Laser for Neurosurgery Use	Laser Engineering, Inc.	GEX	Class II	1988-06-03
K881584	Model Md-45 CO2 Laser for Neurosurgery Use	Laser Engineering, Inc.	GEX	Class II	1988-06-03
K881583	Model Md-25 CO2 Laser for Ear, Nose & Throat	Laser Engineering, Inc.	GEX	Class II	1988-06-03
K881582	Model Md-45 CO2 Laser for Dermatology/podiatry Use	Laser Engineering, Inc.	GEX	Class II	1988-06-03
K881581	Model Md-45 CO2 Laser for Ob-Gyn & Urological Use	Laser Engineering, Inc.	GEX	Class II	1988-06-03
K881580	Model Md-25 CO2 Laser for Derma./plastic Surgery	Laser Engineering, Inc.	GEX	Class II	1988-06-03
K881162	Entera* Enteral Feeding Bag	Smash Ent., Inc.	KNT	Class II	1988-06-03
K881097	Spec 5* Suprapubic Catheter	Porges Corp.	KOB	Class II	1988-06-03
K881075	Lifeport II, Model Lps-1100	Strato Medical Corp.	LJT	Class II	1988-06-03
K880679	Bion Cmv-G Test System	Bion Ent., Ltd.	GQH	Class II	1988-06-03