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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3241 of 3528

510(k) clearances, page 3241 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K812957	East Autoclave Humidifier	Cairco, Ltd.	BTT	Class II	1982-03-12
K820500	Total Lipid Reagent Set	Anco Medical Reagents & Assoc.	CFD	Class I	1982-03-11
K820491	Sgpt Reagent Set	Anco Medical Reagents & Assoc.	CKD	Class I	1982-03-11
K820478	Quinton Q55 Medical Treadmill	Quinton, Inc.	IOL	Class I	1982-03-11
K820473	Enzymatic Cholesterol Reagent System	American Monitor Corp.	CHH	Class I	1982-03-11
K820466	Sgot Reagent Set	Anco Medical Reagents & Assoc.	CIQ	Class II	1982-03-11
K820465	Chemstrip Ug	Biodynamics Corp.	CGA	Class II	1982-03-11
K820462	Emit-St Urine Controls Set a #3A349	Syva Co.	DIF	Class I	1982-03-11
K820461	Emit-St Urine Calibrator a (#3A319	Syva Co.	DKB	Class II	1982-03-11
K820446	Catheter, Multiple Lumen	Dlp, Inc.	GBP	Class I	1982-03-11
K820445	Hearing Aid	Sage Electronics Products, Inc.	ESD	Class I	1982-03-11
K820439	Emit-Amd Amikacin Control	Syva Co.	LAS	Class I	1982-03-11
K820434	Class of Casting Alloys Type III or Alt	Howmedica Corp.	EJS	Class II	1982-03-11
K820433	Class of Casting Alloys Type II or Alter	Howmedica Corp.	EJS	Class II	1982-03-11
K820432	Class of Casting Alloys Type I or Alter	Howmedica Corp.	EJS	Class II	1982-03-11
K820427	Il 8060 Data Management System	Instrumentation Laboratory Co.	JQP	Class I	1982-03-11
K820418	K.d. Colorimetric Blood Urea N2 Test	King Diagnostics, Inc.	JGZ	Class II	1982-03-11
K820415	4150 Alpha Amino Acid Analyzer	Lkb Instruments, Inc.	JJF	Class I	1982-03-11
K820395	Liquizyme Na+/k+ Reagent Set	American Research Products Co.	JGS	Class II	1982-03-11
K820389	A Dental Amalgam Alloy (Unnamed	Dentsply Intl.	EJJ	Class II	1982-03-11
K820321	Immophase B Hcg Radioimmunoassay	Corning Medical & Scientific	JHI	Class II	1982-03-11
K820271	Abbott Laboratories B-Hcg Eia	Abbott Medical	JHI	Class II	1982-03-11
K820228	Min-Molecule Pth by Radioimmunoassay	Immuno Nuclear Corp.	CEW	Class II	1982-03-11
K820192	Haemophilus Influenzae Type B Antiserum	Hyland Therapeutic Div., Travenol Laboratories	GRP	Class II	1982-03-11
K820163	Endosseous Screw Implant	General A. Nitznick, D.M.D.	DZE	Class II	1982-03-11
K820034	Anterior Distraction System	Stuart	KWQ	Class II	1982-03-11
K820028	Zeon Composite Resin Light Cure Sys	National Patent Development Corp.	EBF	Class II	1982-03-11
K812947	Mono-Poly Resolving Medium	Flow Laboratories, Inc.	JCF	Class I	1982-03-11
K820517	Constructa Foam	Alimed, LLC			1982-03-10
K820493	Deep Convex Face Plate	Smith'S Ostomy Products, Inc.	EXB	Class I	1982-03-10
K820442	Argyle Indwell Feeding Tube	Sherwood Medical Co.	KNT	Class II	1982-03-10
K820441	Argyle PVC Feeding Tube	Sherwood Medical Co.	KNT	Class II	1982-03-10
K820423	Suture Removal Tray	Megaplast, Inc.	KDD	Class I	1982-03-10
K820377	Pilling Identi-Loops	Narco Scientific	GAD	Class I	1982-03-10
K820333	Monojector Monolet Lancer	Sherwood Medical Co.	FMK	Class II	1982-03-10
K820238	Cobe Acuflex Ssn, #15-220	Cobe Laboratories, Inc.	LFJ	Class II	1982-03-10
K820237	Cobe Acuflex Fsn, #15-208	Cobe Laboratories, Inc.	LFK	Class II	1982-03-10
K820035	Cdx 200	Cdx Corp.	BZM	Class II	1982-03-10
K813097	Anago Sterile Products; Stockinettes	Anago, Inc.	KKX	Class II	1982-03-10
K820522	Carefree Panty Shields	Personal Products Co.	HHD	Class I	1982-03-08
K820505	Ankle/foot External	Mauch Laboratories, Inc.	ISH	Class I	1982-03-08
K820476	Kem-2	Medical Graphics Corp.	BXB	Class I	1982-03-08
K820474	P-S Suction Reservior	Pudenz-Schulte Medical Research Corp.	GCY	Class I	1982-03-08
K820469	Warm & Form Knee Supports	Thermo-Mold Medical Products, Inc.	IQI	Class I	1982-03-08
K820460	3.5 & 5.5 Oz. Sodium Chloride Solution	Superior Plastic Products Corp.	JOL	Class II	1982-03-08
K820454	The Red Cap	Burron Medical Products, Inc.	FMF	Class II	1982-03-08
K820453	The Int-Stopper	Burron Medical Products, Inc.	FPA	Class II	1982-03-08
K820443	Surgi-Scrape	Consolidated Medical Equipment Company			1982-03-08
K820435	Baxa Addiseal	Baxa Corp., Sub. of Cook Group, Inc.	KPE	Class II	1982-03-08
K820426	Temperature Trend Indicator (Tti)	Mon-A-Therm, Inc.	KPD	Class II	1982-03-08