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 2026-10-29, 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 2689 of 3530

510(k) clearances, page 2689 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883812	Hp-1 (Healthpax)	Healthdirections, Inc.	QJQ	Class II	1988-11-28
K883704	Multiichallenge Nebulizer System	Biotrine Corp.	BTI	Class II	1988-11-28
K882461	O2 Care	Ballard Medical Products	KPJ	Class II	1988-11-28
K882383	Maggi Series Ultra. Needle, Biopsy/catheter Guides	CIVCO Medical Instruments Co., Inc.	DWZ	Class II	1988-11-28
K884656	Disposable Bipolar Cord and Bipolar Forcep	Dermacare	GEI	Class II	1988-11-25
K884029	Ktp/532 Surgical Laser	Laserscope	GEX	Class II	1988-11-25
K883466	Sterile Surgical Gloves	Cal-American Exports, Inc.	KGO	Class I	1988-11-25
K883372	Alpha Mc-9S Mobil C-Arm Image Intensifier Unit	Ausonics Pty, Ltd.	JAA	Class II	1988-11-25
K882639	Palma	Kelso Imports	KGO	Class I	1988-11-25
K881971	Occu-Tech Vision Test	Applied Vision Concepts, Inc.	HOX	Class I	1988-11-25
K884638	Be 410 Endotracheal Tube/trach Tube, Pilot Repair	Instrumentation Industries, Incorporated	BSK	Class II	1988-11-23
K884541	Pro-Vertic 2000 Stand-Up/self-Rising Wheelchair	Pro-Vertic, Inc.	IPL	Class II	1988-11-23
K884374	E.t. Puffer	Kalajian Ent.	BZA	Class I	1988-11-23
K884294	Nicolet Nystar Plus System	Nicolet Instrument Corp.	GWN	Class II	1988-11-23
K884188	Nidek Lm-870 Automatic Lensmeter	Nidek, Inc.	HLM	Class I	1988-11-23
K884148	Diskcam Dc 6001	Camtronics, Ltd.	LMB	Class I	1988-11-23
K884062	Magnetom (M, H, 42, 63) Sequences	Siemens Medical Solutions USA, Inc.	LNH	Class II	1988-11-23
K883662	Berichrom(r) Antithrombin III	Behring Diagnostics, Inc.	JBQ	Class II	1988-11-23
K883476	Voxel Flinger(tm) 3-D Imaging System	Reality Imaging Corp.	LLZ	Class II	1988-11-23
K883202	Ultrasonic Imaging Catheter	Boston Scientific Corporation	DXO	Class II	1988-11-23
K882453	Polyscan Digital Scanner	Medical and Scientific Enterprises, Inc.	IYW	Class I	1988-11-23
K884630	Multi-Purpose Holder	Med-Dex Intl.	LDQ		1988-11-22
K884626	Modified Sliding Reconstitution Device	Baxter Healthcare Corporation	LHI	Class II	1988-11-22
K884574	Dme & Ham's Nutrient Mixture, Prod. No. D9785	Sigma Chemical Co.	KIT	Class I	1988-11-22
K884573	Hbss W/o Calc Chlor/mag Sulf/phen Red/sb No. H4891	Sigma Chemical Co.	KIT	Class I	1988-11-22
K884572	Rpmi-1640 Hybri-Max, Prod. No. R5382	Sigma Chemical Co.	KIT	Class I	1988-11-22
K884510	Modification Micro-Mic	Analytical Products, Inc.	JWY	Class II	1988-11-22
K884509	Modification Mic/api Uniscept(r)	Analytical Products, Inc.	JWY	Class II	1988-11-22
K884419	Technicon Ra-Phenobarbital	Technicon Instruments Corp.	DLZ	Class II	1988-11-22
K884194	Parainfluenza Type 1 Ifa Test Kit for Anti. Detect	Baxter Diagnostics, Inc.	GQS	Class I	1988-11-22
K884193	Parainfluenza Type 3 Ifa Test Kit for Anti. Detect	Baxter Diagnostics, Inc.	GQS	Class I	1988-11-22
K884192	Rsv Ifa Test Kit for Direct Antigen Detection	Baxter Diagnostics, Inc.	LKT	Class I	1988-11-22
K884191	Influenza a Ifa Test for Direct Antigen Detection	Baxter Diagnostics, Inc.	GNX	Class I	1988-11-22
K883851	Msi-Cal 8	Medical Specialties Inc.	KRZ	Class II	1988-11-22
K883850	Msi-Cal 16	Medical Specialties Inc.	KRZ	Class II	1988-11-22
K883822	First Aid Kit, Eye Dressing Nsn6545-00-853-6309	Consolidated Industries of Greater Syracuse, Inc.	HMP	Class I	1988-11-22
K883703	Msi-Cal 7	Medical Specialties Inc.	KRZ	Class II	1988-11-22
K883694	Tensiometer	W. L. Gore & Associates, Inc.	LXH	Class I	1988-11-22
K883212	Lsf (R) Total Hip System - Bipolar Component	Implant Technology, Inc.	KXA	Class II	1988-11-22
K881867	Needle Ejector	Howard, Hills & Harsh	FMF	Class II	1988-11-22
K881670	Accutemp Plus	Sentry Medical Products, Inc.	FMT	Class II	1988-11-22
K880673	Ghb Sample Paper	Isolab, Inc.	LCP	Class II	1988-11-22
K884620	Asd Single Lumen Needle	Biosurge, Inc.	FMI	Class II	1988-11-21
K884542	Sic 3999 Folding Adjustable Hospital Bed	Commercial Products & Engineering Co.	FNJ	Class I	1988-11-21
K884160	Ohmeda - Ohio(r) 3500 Infant Warmer System	GE Healthcare	FMT	Class II	1988-11-21
K884150	Modified Conchatherm III Controlled Heater	Respiratory Care, Inc.	BTT	Class II	1988-11-21
K884084	Portable Oxygen Generator	Mountain Medical Equipment, Inc.	CAW	Class II	1988-11-21
K883994	Vista Mr 2055 Hp System	Philips North America LLC	LNH	Class II	1988-11-21
K883985	Cardiac Cx	Fischer Imaging Corp.	JAA	Class II	1988-11-21
K883872	Cp Head Coil & 260Mm (Cv) Transmit-Receive Coil	Siemens Medical Solutions USA, Inc.	LNH	Class II	1988-11-21