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 2026-10-08, 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 3477 of 3526

510(k) clearances, page 3477 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771602	Myersons Spec. Crown & Bridge Resin	Howmedica Corp.	EBG	Class II	1977-08-30
K771572	Patient Monitors Models 78701A/78702a	Hewlett-Packard Co.	DRR	Class II	1977-08-30
K771552	Las-R Rheumatoid Factor Test	Hyland Therapeutic Div., Travenol Laboratories	DHR	Class II	1977-08-30
K771502	Aneroid Sphygmometer	Swartz Medical Equipment			1977-08-30
K771501	Aneroid Sphygmometer	Swartz Medical Equipment	DXQ	Class II	1977-08-30
K771002	Ice Band	Norcliff Thayer, Inc.	IME	Class I	1977-08-30
K771598	Patella Prosthesis/trail Component	Depuy, Inc.	JWH	Class II	1977-08-26
K771596	Will-Ceram W-3	Williams Gold Refining Co., Inc.	EJS	Class II	1977-08-26
K771581	Stethoscope, Nursescope Type	Swartz Medical Equipment	DQD	Class II	1977-08-26
K771577	Clinical EMG Model 133	Calnor of el Paseo, Inc.	HCC	Class II	1977-08-26
K771534	Biotron 18	Biotronics Corp.	QJQ	Class II	1977-08-26
K771532	Spirometeo & Lung Exerciser, 4601	Boehringer Laboratories, LLC	BWF	Class II	1977-08-26
K771519	Specialist Arm & Leg Protector	Johnson & Johnson Professionals, Inc.	FMP	Class I	1977-08-26
K771506	Stethoscope	Swartz Medical Equipment	DQD	Class II	1977-08-26
K771505	Stethoscope	Swartz Medical Equipment	DQD	Class II	1977-08-26
K771504	Stethoscope	Swartz Medical Equipment	DQD	Class II	1977-08-26
K771463	Aero Pulse Alternating Pres. Pump	MEDLINE INDUSTRIES, LP - Northfield	FNM	Class II	1977-08-26
K771458	Infusion Accelerator	Terumo America, Inc.	KZD	Class I	1977-08-26
K771424	Tube Occluding Forceps	Quinton, Inc.	KOC	Class II	1977-08-26
K771419	Cannula Clamp	Quinton, Inc.	FKC	Class I	1977-08-26
K771406	Gutta Gun	Aus-Tex Dental Mfg. & Design	EIC	Class I	1977-08-26
K771402	Nuva-Cote (Modification to)	L.D. Caulk Co.	EBC	Class II	1977-08-26
K771399	Lip & Cheek Retractor	L.D. Caulk Co.	EIG	Class I	1977-08-26
K771398	Shell Veneer	L.D. Caulk Co.	ELM	Class II	1977-08-26
K771336	Sma II	Technicon Instruments Corp.	JJC	Class I	1977-08-26
K771279	Head Facilitation Vibrator Bk-5210	Fred Sammons, Inc.	IRO	Class I	1977-08-26
K771146	Steoility Testing Vessel	Tower Products, Inc.	JOJ	Class II	1977-08-26
K770974	Cardiozyme Ck-Mb Reagents	Dade, Baxter Travenol Diagnostics, Inc.			1977-08-26
K771607	Hearing Aid Model 775	Danavox, Inc.	ESD	Class I	1977-08-25
K771588	Platelet Controls Normal & Abnormal	Dade, Baxter Travenol Diagnostics, Inc.	GJP	Class II	1977-08-25
K771571	Mobile X-Ray Sys. Model 43820A	Hewlett-Packard Co.	IZL	Class II	1977-08-25
K771562	Agglutinating Serum W135	Burroughs Wellcome Co.	GTJ	Class II	1977-08-25
K771559	Hema-Tek II Slide Stainer	Miles Laboratories, Inc.	KPA	Class I	1977-08-25
K771553	Spiral Scalp Electrode, 14499A	Hewlett-Packard Co.	HGP	Class II	1977-08-25
K771549	Versatome	Kermath Mfg. Corp.	IZF	Class II	1977-08-25
K771541	Fetal Monitoring System	Air-Shields, Inc.	HGM	Class II	1977-08-25
K771533	Digoxin Ria Kit	G.D. Searle and Co.	DNJ	Class II	1977-08-25
K771530	Temp. Crown Acrylic Resin	J. Palmero Sales Co., Inc.	EBG	Class II	1977-08-25
K771526	125 I Aldosterone Ria Kit	Siemens Healthcare Diagnostics Inc.	CJM	Class II	1977-08-25
K771255	Cebtria Digoxin Ria	Union Carbide Corp.	DON	Class II	1977-08-25
K771253	Hemox-Analyzer	3M Company	CHL	Class II	1977-08-25
K771556	Exr	Litton Dental Products	ELC	Class II	1977-08-22
K771538	Lithicron Model 3-70C-B Pulse Generator	Medcor, Inc.	DXY	Class III	1977-08-22
K771524	Histochemical Ferric Iron Set	Harleco	IAE	Class I	1977-08-22
K771513	Kem-O-Mat	Coulter Electronics, Inc.	JJF	Class I	1977-08-22
K771497	Ck-Mb	Boehringer Mannheim Corp.	JHT	Class II	1977-08-22
K771489	Rterial Blood Sampling Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	GJE	Class II	1977-08-22
K771486	Dual Lab-Lite Light Box	Technilab	DJS	Class I	1977-08-22
K771478	Infusion Pump #6202	Roche Medical Electronics, Inc.	FRN	Class II	1977-08-22
K771453	Fluid Handling Device W/input Tubing	Imed Corp.	FPA	Class II	1977-08-22