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 2707 of 3530

510(k) clearances, page 2707 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881984	Eol, Model Lio	Eol, Inc.	HLI	Class II	1988-09-06
K881893	Numed Balloon Thermodilution Catheter	Numed Inc	KRB	Class II	1988-09-06
K880923	Patient Ventilator Isolator	Dryden Corp.	CBK	Class II	1988-09-06
K880725	Sam(tm) Model One	Sentel Tech. C/O Criticare Systems, Inc.	BZQ	Class II	1988-09-06
K880534	Zephyr	Racal Health & Safety, Inc.	FXX	Class II	1988-09-06
K883599	Lx-80 Automated Tissue Processor (Plastic)	Innovative Medical Systems, Inc.	IEO	Class I	1988-09-02
K883527	Grid/radiographic	Umi, Inc.	IXJ	Class I	1988-09-02
K883521	C/r Gating for Its Vista Mr 2055/2055 Up & Hp Sys	Philips North America LLC	LNH	Class II	1988-09-02
K883433	Ambu Twin Pump - (Manual Suction Pump)	Ambu, Inc.	GCY	Class I	1988-09-02
K883081	Radkor, Xg-515	Radkor, Inc.	IZO	Class I	1988-09-02
K883020	Rfa-300 Rapid Flow Analyzer W/computer	Alpkem Corp.	JJF	Class I	1988-09-02
K882603	Stachrom Antiplasmin Control	American Bioproducts Co.	GGP	Class II	1988-09-02
K882602	Stachrom Antiplasmin Test Kit	American Bioproducts Co.	GGP	Class II	1988-09-02
K882496	Abuscreen(r) Ontrak(tm) for Morphine	Roche Diagnostic Systems, Inc.	DJG	Class II	1988-09-02
K882433	Laryngoscope Rigid	Eastmed Enterprises, Inc.	CCW	Class I	1988-09-02
K882365	Heraeus Lasersonics Nd:yag Laser, Model 4900	Heraeus Lasersonics, Inc.	GEX	Class II	1988-09-02
K882329	L-F Coiled Extension Tubing	Mallinckrodt Group, Inc.	DXT	Class II	1988-09-02
K881700	Radkor Kob-84	Radkor, Inc.	KXJ	Class II	1988-09-02
K881696	Radkor Xg-325	Radkor, Inc.	IZO	Class I	1988-09-02
K881674	Shimadzu Whole Body X-Ray CT Scanner Sct-3000Tc	Shimadzu Precision Instruments, Inc.	JAK	Class II	1988-09-02
K875285	Multi-Chemistry Linearity Standard	Verichem Laboratories, Inc.	JIX	Class II	1988-09-02
K874288	Phadebact Etec-Lt Test	Pharmacia, Inc.	GNA	Class I	1988-09-02
K883513	Hearing Aid, Unitron Model Vista 1000	Unitron Industries, Inc.	ESD	Class I	1988-09-01
K882757	Argyle Autotransfusion Bag	Sherwood Medical Co.	CAC	Class II	1988-09-01
K881662	Expanded Claimes to Osteogen(r)	Impladent, Ltd.	DZE	Class II	1988-09-01
K880878	Cx250 Mobile Gamma Camera & Dcs Console	Philips North America LLC	IYX	Class I	1988-09-01
K880857	Syringe Pump Ms2000	Smash Ent., Inc.	FRN	Class II	1988-09-01
K881936	Oper-Film-Adhesive Membrane	Iberhospitex, S.A.	NAD	Class I	1988-08-31
K881842	Tracer	Life-Tech Intl., Inc.	BXN	Class II	1988-08-31
K881779	Whiteside Ortholoc II Unicondylar Knee System	Dow Corning Wright	HSX	Class II	1988-08-31
K881731	Ad-Heal(tm) Wound Dressing	Nepera, Inc.	NAD	Class I	1988-08-31
K883451	Sfre 199-1 Medium, Catalog No. 200-2191	J R Scientific	KIT	Class I	1988-08-30
K883375	Model #918 Multi-Pads	Cardiotronics, Inc.	DRO	Class II	1988-08-30
K883294	Synthetic Cast Tape	Carapace, Inc.	LGF	Class I	1988-08-30
K883225	Flossie	Richard G. Deniro	JET	Class I	1988-08-30
K883059	Wako(tm) Autokit Amylase	FUJIFILM Healthcare Americas Corporation	CJA	Class II	1988-08-30
K883055	Dart Carbon Dioxide	Coulter Electronics, Inc.	KHS	Class II	1988-08-30
K883052	Metheno-Stain Kit	Scientific Device Laboratory, Inc.	JTS	Class I	1988-08-30
K882914	Vista Instrument	Abbott Medical	JJE	Class I	1988-08-30
K882913	Dtr Analyzer	Abbott Medical	JJE	Class I	1988-08-30
K882823	Fiagen Hgh Fluoroimmunoassay Kit	Cyberfluor, Inc.	CFL	Class I	1988-08-30
K882741	Allegro Acth Immunoassay Kit 65 and 130 Tubes	Nichols Institute Diagnostics	CKG	Class II	1988-08-30
K882738	L.p.i. Laser Delivery System	Laser Photonics, Inc.	GEX	Class II	1988-08-30
K882722	Houva-Bed	National Biological Corp.	FTC	Class II	1988-08-30
K882691	Model P4/p4x Behind-the-Ear Hearing Aid W/phox	Maico Hearing Instruments, Inc.	ESD	Class I	1988-08-30
K882687	Anti-Respiratory Syncytial Virus Antibody Test	Gull Laboratories, Inc.	LKT	Class I	1988-08-30
K882555	Anotron(r) Incontinence Control System	Biosonics, Inc.	KPN	Class II	1988-08-30
K882481	Hemochron Control Act Test Tube Normal/abnor. i/ii	Accriva Diagnostics, Inc.	GGN	Class II	1988-08-30
K882480	Hemochron Control Plasma Normal/abnormal Lev. i/ii	Accriva Diagnostics, Inc.	GGN	Class II	1988-08-30
K882393	Digital Blood Pressure Monitor Model Hem-703Cp	Omron Electronics, Inc.	DXN	Class II	1988-08-30