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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2143 of 3531

510(k) clearances, page 2143 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945342	Mag-1 Spectacle Frame	Criss Optical Mfg. Co., Inc.	HQZ	Class I	1994-11-28
K945161	Norelco Clean Air System Cas950	Hogan & Hartson	FRF	Class II	1994-11-28
K945054	Endocare Prolase I Advanced Laser Delivery System	Cytocare, Inc.	GEX	Class II	1994-11-28
K944927	Norelco Clean Air System Cas900	Norelco Consumer Products Co.	FRF	Class II	1994-11-28
K944883	Gamma Locking Nail - Long Length	Howmedica Corp.	KTT	Class II	1994-11-28
K944514	P2 Nitrile Exam Gloves	Biosafety Systems, Inc.	LYZ	Class I	1994-11-28
K944501	True/flex Intramedullary Rod End-Cap	Applied Osteo Systems, Inc.	HSB	Class II	1994-11-28
K944423	Power Recliner	Sunrise Medical, Inc.	ITI	Class II	1994-11-28
K944415	Origin Tacker System	Origin Medsystems, Inc.	OCW	Class II	1994-11-28
K944204	Lateralase, Modified	Trimedyne, Inc.	GEX	Class II	1994-11-28
K943926	Rapido 2000 Automatic Radiographic Table	Philips North America LLC	IZZ	Class II	1994-11-28
K943898	Saunders Electronic Inclinometer	The Saunders Group	KQX	Class I	1994-11-28
K943891	Rd Culture Cell	Neogenex	KIR	Class I	1994-11-28
K943890	Wi38 Cell Culture	Neogenex	KIR	Class I	1994-11-28
K943889	Vero Cell Culture	Neogenex	KIR	Class I	1994-11-28
K943888	Mdck Cell Culture	Neogenex	KIR	Class I	1994-11-28
K943887	Human Newborn Foreskin Cell Culture	Neogenex	KIR	Class I	1994-11-28
K943886	Bgm Cell Culture	Neogenex	KIR	Class I	1994-11-28
K943885	Primary Rabbit Kidney Cell Culture	Neogenex	KIR	Class I	1994-11-28
K943884	Primary Monkey Kidney Cell Culture	Neogenex	KIR	Class I	1994-11-28
K943809	Monogard Face Shield	White Knight Healthcare	LYU	Class I	1994-11-28
K943730	Squeeze Play	Conair LLC.	IRO	Class I	1994-11-28
K943722	Chemotherapy Sharps Disposal Containers	Baxter Healthcare Corporation	FMI	Class II	1994-11-28
K943595	Serum/urine Appli Ilab(tm) Clinical Chemistry System	Instrumentation Laboratory Co.	JJQ	Class I	1994-11-28
K943447	V-Max Options	Philips North America LLC	JAA	Class II	1994-11-28
K943427	Ace Cedia Cortisol Assay	Schiapparelli Biosystems, Inc.	CGR	Class II	1994-11-28
K943323	Stryker Surgical Instruments and Accessories	Stryker Corp.	HRX	Class II	1994-11-28
K943238	Norelco Clean Air System	Philips Electronic North America Corp. (Pena)	FRF	Class II	1994-11-28
K943146	Porta-Resp Monitor	S & M Instrument Co.	CAP	Class II	1994-11-28
K943139	B-D Guardian One Piece Sharps Collectors	Med-Safe Systems, Inc.	FMI	Class II	1994-11-28
K943138	Vacutainer Brand Needle Disposal Container	Med-Safe Systems, Inc.	MMK	Class II	1994-11-28
K943012	Calibrator	Prisma Systems	JIX	Class II	1994-11-28
K942683	Bionaire Hepa Air Purifiers /Sh-1240, 1260, 1840, 1860, Ch-3550	Bionaire Corp.	FRF	Class II	1994-11-28
K942339	Skin Neuveau Scar Treatment	Puritas Health Care, Inc.	MDA	Class I	1994-11-28
K942336	Automatic Digital Blood Pressure Monitor	Integrated Display Technology, Ltd.	DXN	Class II	1994-11-28
K942093	Remel Rim Streptococcus Grouping Latex Agglutination Test	Medical Diagnostic Technologies, Inc.	GTZ	Class I	1994-11-28
K941866	Pioneer Laboratories Cable Screw	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HWC	Class II	1994-11-28
K940661	Stiegmann-Goff Endoscopic Ligator	C.R. Bard Inc	MND	Class II	1994-11-28
K940322	Arbo Vs Monitor Cable & Leadwire System Arbo Shielded Safety Cable & Lead Wire	Arbo Medical, Inc.	DSA	Class II	1994-11-28
K940189	Coil Positioner Set	Cook Inc.	KRD	Class II	1994-11-28
K935926	Storz Phaco and Frag Handpieces	Storz Instrument Co.	HQC	Class II	1994-11-28
K935921	Zirconia Ceramic Femoral Head	Smith & Nephew Richards, Inc.	LZO	Class II	1994-11-28
K933575	Virastat(r) Fitc-Label Anti-Parainflu 1,2&3 Mono Ant	Symex Corp.	GQP	Class I	1994-11-28
K933184	Positive Airway Pressure System	Innovative Medical Systems, Inc.	BZD	Class II	1994-11-28
K944198	Surgical Microscope Drape	Hydro-Med Products, Inc.	MMP	Class II	1994-11-27
K945450	Frame, Spectacle	Kookje Apis Industrial Co.	HQZ	Class I	1994-11-22
K945438	Edi-Bur Microdrill Systems	Micromed Development Corp.	ERL	Class II	1994-11-22
K945415	'Lil Mac Accessory Clamp(tm)	D.L. Nelson and Assoc., Inc.	FWZ	Class I	1994-11-22
K945369	Laparoscopic Surgical Instruments for General Use	Advanced Surgical, Inc.	GCJ	Class II	1994-11-22
K945346	Makrolon 2405 Goggles (Light and Dark)	Universal Massage & Tanning, Inc.	HOY	Class I	1994-11-22