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 2026-10-22, 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 2917 of 3529

510(k) clearances, page 2917 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860888	Connectors/valve Insert	Dhd Medical Products Div. Diemolding Corp.	BZA	Class I	1986-03-19
K860887	T-Pieces Connectors	Dhd Medical Products Div. Diemolding Corp.	BZA	Class I	1986-03-19
K860886	Straight Connectors, 22Mm	Dhd Medical Products Div. Diemolding Corp.	BZA	Class I	1986-03-19
K860884	Self-Sealing Water Trap/accessories	Dhd Medical Products Div. Diemolding Corp.	BYH	Class I	1986-03-19
K860883	Self-Sealing Water Trap/adult/paediatric Circuits	Dhd Medical Products Div. Diemolding Corp.	BYH	Class I	1986-03-19
K860881	Catheter Mounts & Elbows (Various Types)	Dhd Medical Products Div. Diemolding Corp.	BZA	Class I	1986-03-19
K860874	Venturi Mask W/humdification Cup Adult/paediatric	Dhd Medical Products Div. Diemolding Corp.	BYF	Class I	1986-03-19
K860872	Nasal Cannula W/2m & 5M Tubing	Dhd Medical Products Div. Diemolding Corp.	CAT	Class I	1986-03-19
K860871	Tracheostomy Masks/adult & Paediatric	Dhd Medical Products Div. Diemolding Corp.	BYG	Class I	1986-03-19
K860870	Aerosol Masks/adult & Paediatric	Dhd Medical Products Div. Diemolding Corp.	BYG	Class I	1986-03-19
K860869	Medium Concentration Oxygen Masks	Dhd Medical Products Div. Diemolding Corp.	BYG	Class I	1986-03-19
K860701	Hps II Smooth Stem	Depuy, Inc.	JDI	Class II	1986-03-19
K860592	Ace Im Rod	Buckman Co., Inc.	HSB	Class II	1986-03-19
K860352	Spacelabs Airway Adapter Set Series, No. 369014	Spacelabs, Inc.	BZA	Class I	1986-03-19
K860131	Acromed Spinal Surgery Instruments	Buckman Co., Inc.	LXH	Class I	1986-03-19
K860016	Aesculap Bone Mill	Aesculap Instruments Corp.	LYS	Class I	1986-03-19
K853805	Micro-Media Microdilution Test Panels	Beckman Instruments, Inc.	JWY	Class II	1986-03-19
K860862	Campylobacter Cva Agar	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1986-03-18
K860793	Camco Stain Pak	Cambridge Chemical Products, Inc.	IAF	Class I	1986-03-18
K860789	Jmd Av Fistula Needle (Modification)	JMS Co., Ltd.	FIE	Class II	1986-03-18
K860751	Von Willebrand Fac. Defic. Abnormal Control Plasma	Bio/Data Corp.	JPK	Class II	1986-03-18
K860571	F.m. Weist,kg (Urodynamic Systems)	F.M. Wiest USA, Inc.	FAP	Class II	1986-03-18
K860468	Unicaddy I & II i.v. Container Caddy Ims Pole Mate	Intl. Medication Systems, Ltd.	FOX	Class I	1986-03-18
K860290	Viapic Central Line Catheter	Parke-Davis Co.	FOZ	Class II	1986-03-18
K860272	Solution Administration Sets	Travenol Laboratories, S.A.	FPA	Class II	1986-03-18
K860084	Pressure Infusor #1900	Pa Medical Corp.	KZD	Class I	1986-03-18
K855054	The Wood Pump 'Ole Red'	T.C. Retigo, Inc.	KZD	Class I	1986-03-18
K854978	Difco Strep a Latex Test	Difco Laboratories, Inc.	GTZ	Class I	1986-03-18
K854318	Lifeport Ambulatory Infusion Pump	Strato Medical Corp.	FRN	Class II	1986-03-18
K854265	Simulator	Cygnus of South Florida, Inc.	JQP	Class I	1986-03-18
K853664	Heparin Micro-Infusor	Y	FRN	Class II	1986-03-18
K853450	Steristorage Container	K-Seven Industries, Inc.	FMF	Class II	1986-03-18
K860817	Root Canal Organizer	Pacific Union Dental, Inc.	EIK	Class I	1986-03-17
K860690	Triglycerides for Continuous Flow Instruments	Catachem, Inc.	CDT	Class I	1986-03-17
K860684	Sandare Bcg Albumin Procedure	Sandare Chemical Co., Inc.	CIX	Class II	1986-03-17
K860625	Glucose Hk-60 Assay Kit Cat. #201-39	Diagnostic Chemicals, Ltd. (USA)	CFR	Class II	1986-03-17
K860512	Telestar I, Hearing Aid	The Florida Hearing Aid Service	ESD	Class I	1986-03-17
K860437	Partial Denture Alloy	Dentsply Intl.	EJH	Class II	1986-03-17
K860423	A-Gent Liquid Albumin	Abbott Medical	CJW	Class II	1986-03-17
K860365	Phenobarbital Test System	Allied Instrumentation Laboratory	DLZ	Class II	1986-03-17
K860355	Bovine Chemistry Control i.x and Ii.x	American Dade	JJY	Class I	1986-03-17
K860348	Gamma Glutamyl Transpeptidase (Ggtp) Reagent Set	Sterling Diagnostics, Inc.	JPZ	Class I	1986-03-17
K860313	3.0 Mhz Linear Array Probe Model Ust 5031	Johnson & Johnson Professionals, Inc.	HGL	Class II	1986-03-17
K860308	Sucrosep Luteinizing Hormone (Lh) Irma	Boots-Celltech Diagnostics, Inc.	CEP	Class I	1986-03-17
K860299	Realor Alloy	Degussa Dental, Inc.	EJS	Class II	1986-03-17
K860217	Ncm - Alpha Alloy (Dental Bake-on Alloy)	Austenal Dental, Inc.	EJH	Class II	1986-03-17
K860214	Total Bilirubin Reagent Set	Sterling Diagnostics, Inc.	CIG	Class II	1986-03-17
K860197	Series 410 Lc Pump	Revvity Health Sciences, Inc.	KZR	Class I	1986-03-17
K860192	Endoport 5Mm Single-Use Trocar and Sleeve	Endotherapeutics	HET	Class II	1986-03-17
K860146	Polyjel N.f. (New Formula)	Dentsply Intl.	ELW	Class II	1986-03-17