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 2803 of 3530

510(k) clearances, page 2803 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872597	Fine Needle Aspiration Biopsy System-Prostate	Dianon Systems, Inc.	DWO	Class I	1987-07-28
K872518	Rem500 Three Wheeled Elec. Cart.	Royal Enterprises Manufacturing, Inc.	INI	Class II	1987-07-28
K872474	Post-Auricular Hearing Aid Model Pe 805 Scd2	Phonic Ear, Inc.	ESD	Class I	1987-07-28
K872473	Post-Auricular Hearing Aid Model Pe 805Cd2	Phonic Ear, Inc.	ESD	Class I	1987-07-28
K872375	Widex Hearing Aid Model Es6	Widex Hearing Aid Co., Inc.	ESD	Class I	1987-07-28
K871879	Sofswab	Plastic Engineered Products Co.	EFW	Class I	1987-07-28
K871679	Focus-Ghb	Awareness Technology, Inc.	LCP	Class II	1987-07-28
K871619	Lpm-1 (Laser Power Meter)	Bio-Tek Instruments, Inc.	GEX	Class II	1987-07-28
K872821	Infusion Pump Enclosure	Pharmacia Deltec, Inc.	FRN	Class II	1987-07-27
K872783	Ampicillin/sulbactam 20 Mcg Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1987-07-27
K872707	Panosol 2000 624-404	National Biological Corp.	FTC	Class II	1987-07-27
K872706	Panosol 2000 624-616	National Biological Corp.	FTC	Class II	1987-07-27
K872659	Tapeless Eye Shield	Precision Therapeutics, Inc.	HOY	Class I	1987-07-27
K872651	Panosol 2000 624-414	National Biological Corp.	FTC	Class II	1987-07-27
K872650	Panosol 2000 624-604	National Biological Corp.	FTC	Class II	1987-07-27
K872649	Hand/foot Uva/uvb 624-224	National Biological Corp.	FTC	Class II	1987-07-27
K872584	Fortec Mi-306, Mi-327 Digital Thermometer	Nam Tai, Ltd.	FLL	Class II	1987-07-27
K872506	Melanite I	Aura Lens Products	HQG	Class I	1987-07-27
K872503	Fh Len	Fu Heng First Industrial Co., Ltd.	HQY	Class I	1987-07-27
K872399	t.e.n.s. Device Model Spl 2000S	Spartan Laboratories, Inc.	GZJ	Class II	1987-07-27
K872362	Frigitronics Acc-1000 Capsule Cutter	Frigitronics of Connecticut, Inc.	HQC	Class II	1987-07-27
K872322	Emds Gamma-Glutamyl Transferase (Ggt) 67680/95	Em Diagnostic Systems, Inc.	JQB	Class I	1987-07-27
K872320	Easy-Test Gamma-Glutamyl Transferase (Ggt) 16616	Em Diagnostic Systems, Inc.	JQB	Class I	1987-07-27
K871908	IV Administration Set	Travenol Laboratories, S.A.	BRZ	Class II	1987-07-27
K871854	In-Line Ophthalmic Irrigating Solution Filters	CooperVision, Inc.	HQC	Class II	1987-07-27
K871728	Modified Lifecare(r) 4100 Pca Infuser	Abbott Medical	FRN	Class II	1987-07-27
K871726	Ovuquick Self-Test (Ovuquick; Ramp Lh Assay)	Monoclonal Antibodies, Inc.	CEP	Class I	1987-07-27
K864544	Diabetes Risk Detector	Pearce Clinical Laboratories, Inc.	JIL	Class II	1987-07-27
K872605	Hand/foot Uva 624-218	National Biological Corp.	FTC	Class II	1987-07-24
K872604	Hand/foot 624-208	National Biological Corp.	FTC	Class II	1987-07-24
K872558	Cart, Emergency, Cardiopulmonary	Nico Metal Products Corp.	BZN	Class I	1987-07-24
K872160	Dideco-Shiley Blood Separation Wash Bowl	Shiley, Inc.	CAC	Class II	1987-07-24
K872117	Dextranomer	Interworld, Inc.	KOZ	Class I	1987-07-24
K872037	Aerochamber	Monaghan Medical Corp.	BYP	Class I	1987-07-24
K871466	Vestibular Autorotation Test	Western Systems Research, Inc.	GWN	Class II	1987-07-24
K871400	Ssd-650 Linear, Convex Sector, Ultrasound Scanning	GE Medical Systems Information Technologies, Inc.	DXK	Class II	1987-07-24
K864913	Cutinova(r) Plus Foam Gelfilm	Beiersdorf, Inc.	FRO	Unclassified	1987-07-24
K872796	Additions to Wsl Nitrospray Cryosurgical Units	Tower Mfg. Co., Inc.	GEH	Class II	1987-07-23
K872751	Fluortran - C(tm)	Para Scientific Co.	LIO	Class I	1987-07-23
K872729	Infusion Stand	Camtec	FOX	Class I	1987-07-23
K872653	Easy-Test Hemoglobin (Hgb) Item #16685	Em Diagnostic Systems, Inc.	KHG	Class II	1987-07-23
K872599	Qm300 C4 Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DBI	Class II	1987-07-23
K872595	Holding Rod, Surgical Forceps, Weinstein,12x2 3/4	Grimm & Norton			1987-07-23
K872574	Tensagain	Ferris Mfg. Corp.	GXY	Class II	1987-07-23
K872527	Omron Digital Fever Thermometer Model Mc-12B	Omron Electronics, Inc.	FLL	Class II	1987-07-23
K872502	M.w.p. Wrist Prosthesis	Protek, Inc.	KWM	Class II	1987-07-23
K872490	1.1 Screwdrivers	Micro-Aire Surgical Instruments, Inc.	LRZ	Class I	1987-07-23
K872460	An3000 Mahoney Drain	H.W. Andersen Products, Inc.	GBS	Class I	1987-07-23
K872426	Cytotech C1-Inhibitor Enzyme Immunoassay	Cytotech, Inc.	DBA	Class II	1987-07-23
K872393	Sonopuls 463, Ultrasound Therapy Equipment	Henley Intl.	IMI	Class II	1987-07-23