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 2282 of 3531

510(k) clearances, page 2282 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920865	Sharplan 2100,3000,Sharplaser 65, 40	Sharplan Lasers, Inc.	GEX	Class II	1993-08-02
K920238	Private Labels and Femtex	First Quality Hygienic, Inc.	HEB	Class II	1993-08-02
K905663	Pediatric Intra-Aortic Balloon Catheters	Datascope Corp.	DSP	Class II	1993-08-02
K932139	Lighted Intubation Stylet W/replaceable Shaft	Apyx Medical Corporation	FSQ	Class II	1993-07-30
K931037	Whitmore Vacuum-Lock Spinal Frame (Vlsf-100)	Whitmore Ent., Inc.	FWZ	Class I	1993-07-30
K930855	Replacement Cap	Douglas Medical Products, Inc	FPA	Class II	1993-07-30
K930711	Tri*star	Light Technology Systems	FSS	Class II	1993-07-30
K930686	Midmark Surgical Lighting Systems	Midmark Corp	FSQ	Class II	1993-07-30
K926403	Pro-2000 Low Air Loss Therapy Bed	Ch Administration, Inc.	FNM	Class II	1993-07-30
K925744	Tempa-Kuff Single Pat Pre-Gaged Balanced Disp Cuff	Pymah Corp.	DXQ	Class II	1993-07-30
K925556	Argyle Aspir-Flex Suction Catheter	Sherwood Medical Co.	BSY	Class I	1993-07-30
K925396	Pulse Guard Electrode	Northgate Technologies Inc.	FFK	Class II	1993-07-30
K925313	Titanium Coc Abutment Heads for Imz	Implant Support Systems, Inc.	DZE	Class II	1993-07-30
K925228	Ivac 59 Series Universal Set W/ Anti-Free Flow Val	Y	FPA	Class II	1993-07-30
K924677	Strato Medical Infuse-a-Cath Polyure Cen Ven Cath	Strato Medical Corp.	LJS	Class II	1993-07-30
K924372	Laparoscopic Nerve Hook	Nusurg, Inc.	GCJ	Class II	1993-07-30
K923487	Bal Cath	Ballard Medical Products	KTR	Class II	1993-07-30
K920912	The Medic Tm	Medical and Environment Designs, Inc.	GCX	Class II	1993-07-30
K933262	Bird Avian Port Military Vent Nsn 6530-01-374-8903	Bird Products Corp.	CBK	Class II	1993-07-29
K932092	Usci Angiographic Catheter	C.R. Bard Inc	DQO	Class II	1993-07-29
K931292	Multiview for Windows	Image Data Corp.	LMD	Class I	1993-07-29
K926349	Probloc Insulated Needles	Life-Tech Intl., Inc.	GXZ	Class II	1993-07-29
K925910	Hewlett-Packard Model M1018a Tcpo2/topco2 Module	Hewlett-Packard Co.	KLK	Class II	1993-07-29
K925827	Impraflo(tm) Post Operative/drain/reinfus Kit/cani	Impra, Inc.	CAC	Class II	1993-07-29
K925803	A.j. Morgan Sunglasses	A.J. Morgan Ent.	HQY	Class I	1993-07-29
K925631	Phacotron Gold Multifunction Ultrasonic Handpiece	Chiron Intraoptics	HQC	Class II	1993-07-29
K925446	Bard Safe Sampling Device	C.R. Bard Inc	FMI	Class II	1993-07-29
K924544	Cardiax	Fairlake Marketing Group, Inc.	DPS	Class II	1993-07-29
K924511	Monoject(r) 6 Cc Safety Syringe	Sherwood Medical Co.	FMF	Class II	1993-07-29
K924308	Gastroport II	Sandoz Nutrition	KNT	Class II	1993-07-29
K924303	Tampax Tampon, Regular Absorbency	Tambrands Inc.	HEB	Class II	1993-07-29
K923932	Tampax Tampons, Super Absorbency	Tambrands Inc.	HEB	Class II	1993-07-29
K922418	Video Endoscope System	Baxter Healthcare Corporation	HET	Class II	1993-07-29
K920760	Peri-K Pad Cold Pack	Baxter Healthcare Corporation	IMD	Class I	1993-07-29
K932659	Multi Level Control for Ckmb Isoensyme in Syrum	More Diagnostics Inc.	JJX	Class I	1993-07-28
K932658	Ckmb Isoenzyme Control(human) Level 1,2,& 3	More Diagnostics Inc.	JJX	Class I	1993-07-28
K932022	Entree Thoracoscopy Cannula Set	Core Dynamics, Inc.	GCJ	Class II	1993-07-28
K931898	Endoswab	MEDLINE INDUSTRIES, LP - Northfield	GCJ	Class II	1993-07-28
K931631	Coated Orthodontic Devices	Wonder Wire	DZC	Class I	1993-07-28
K931506	Urine Calibrator and Control	Diagnostic Reagents, Inc.	DLJ	Class II	1993-07-28
K931376	Gammacon Image Translation System	Numa Corp.	LLZ	Class II	1993-07-28
K931366	Tri-Point Liquimmune Immuonassay Control, L-1,2,3	Medical Analysis Systems, Inc.	JJY	Class I	1993-07-28
K931223	Fujinon Video Laparoscope--Thoracoscopy	FUJIFILM Healthcare Americas Corporation	GCJ	Class II	1993-07-28
K930981	Acculite(tm) Otoprobe	Coherent Medical Group	GEX	Class II	1993-07-28
K930817	Laparoscopic Lymphadenectomy	FUJIFILM Healthcare Americas Corporation	GCJ	Class II	1993-07-28
K930178	Electro Floss	Arizona Implant Dentistry	JET	Class I	1993-07-28
K930099	Laser Handpiece Shroud	I.C. Medical, Inc.	GEX	Class II	1993-07-28
K930098	Speculum Smoke Evacuator Tubing	I.C. Medical, Inc.	GEX	Class II	1993-07-28
K930097	Electrocautery Shroud	I.C. Medical, Inc.	GEI	Class II	1993-07-28
K926210	Eclipse 3200	Cardiogenes	GEX	Class II	1993-07-28