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 2738 of 3530

510(k) clearances, page 2738 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881106	Acid Fast Bacilli Histology Control Slides	Sigma Diagnostics, Inc.	LJG	Class I	1988-04-21
K881098	Modified Neo-I Temperature, Conductivity Meter	Automata, Inc.	FIZ	Class II	1988-04-21
K881062	Centry 2 Ultrafiltration Control Kit, #018762-002	Cobe Laboratories, Inc.	FJB	Class II	1988-04-21
K881010	CO2 Rigid Laser Endoscope Probe Series 792/Laparo	Sharplan Lasers, Inc.	HET	Class II	1988-04-21
K880970	Axillary Block Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	CAZ	Class II	1988-04-21
K880948	Rich-Mar G1000 Ems	Rich-Mar Corp.	IPF	Class II	1988-04-21
K880897	Nova Gel (Tm) Scl-70	Inova Diagnostics, Inc.	LLL	Class II	1988-04-21
K880892	Blood Collecting Needle and Holders	Abco Dealers, Inc.	FMI	Class II	1988-04-21
K880719	Pharmacia B2-Micro Ria	Pharmacia, Inc.	JZG	Class II	1988-04-21
K880714	Diasonics Qt Endorectal 7.5 Mhz Probe	Diasonics, Inc.	IYO	Class II	1988-04-21
K880653	Hbf Diluent	Helena Laboratories, Corp.	KQI	Class II	1988-04-21
K880631	2K-Qda Motion/gait Analysis System	Human Performance Technologies, Inc.	LXJ	Class II	1988-04-21
K880623	Minimed Model 404-Sp External Infusion Pump	Medtronic, Inc.	FRN	Class II	1988-04-21
K880569	Teammate(tm)	Infusion Systems Corp.	FRN	Class II	1988-04-21
K880567	White Ash Allergen Disc	Incstar Corp.	DHB	Class II	1988-04-21
K880415	Mesquite Allergen Disc	Incstar Corp.	DHB	Class II	1988-04-21
K880207	Expandover Elastic Bandage	Expandover C/O Hale and Dorr	KGX	Class I	1988-04-21
K880187	Incstar's Dandelion Allergen Disc	Incstar Corp.	DHB	Class II	1988-04-21
K880160	Dpc's Allergen-Specific Ige System	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1988-04-21
K880038	For the Deter. of Hemoglobin in Plasma #527	Sigma Diagnostics, Inc.	KHG	Class II	1988-04-21
K875363	Serodot Toxoplasma Igg Test Kit	Disease Detection International, Inc.	LGD	Class II	1988-04-21
K875244	Alleia (Tm) Allergen Specific Ige System	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1988-04-21
K875163	Goldenrod Allergen Disc	Incstar Corp.	DHB	Class II	1988-04-21
K875075	Rt-200 Computer Interface	Timeter Instrument Corp.	BXX	Class I	1988-04-21
K874770	Tdx (R) Amphetamine Class	Abbott Medical	DKZ	Class II	1988-04-21
K873659	Musculoskeletal Evaluation Rehabilitation/conditio	Universal Gym Equipment, Inc.	IKK	Class II	1988-04-21
K873658	Ankle Reflex Treatment Unit (Artu)	Universal Gym Equipment, Inc.	BXB	Class I	1988-04-21
K871792	Veolar Ventilator	Hamilton Medical AG	CBK	Class II	1988-04-21
K881492	Mti Wolff System, Tanning Bed	Health Systems Intl., Inc.	LEJ	Class II	1988-04-19
K881427	Spirix(tm)	Medical/Surgical Specialties, Ltd.	GEI	Class II	1988-04-19
K881409	Sun Shell (Sun Tanning Bed)	Indoor Sun Systems, Inc.	LEJ	Class II	1988-04-19
K881359	Decalcifying Solution II	Stephens Scientific	KOX	Class I	1988-04-19
K881225	Ophthalmic Spectacle Lens Blanks	Beta Optical Co, Inc.	HQG	Class I	1988-04-19
K881040	Emit Vancomycin Assay	Syva Co.	LEH	Class II	1988-04-19
K880968	Model 2001 Phacoemulsifier Aspirator	Mcghan Instrumed Corp.	HQE	Class II	1988-04-19
K880867	Amylase 405 Catalog Number 301-34	Diagnostic Chemicals, Ltd. (USA)	JFJ	Class II	1988-04-19
K880863	Bipolar Micro Coagulator Models 25-1000 & 25-1200	New England Surgical Instrument Corp.	GEI	Class II	1988-04-19
K880625	Half Hour Infusor	Baxter Healthcare Corporation	FRN	Class II	1988-04-19
K880290	Microtrak Cmv Culture Confirmation Test	Syva Co.	GQH	Class II	1988-04-19
K880260	Safecath	Phase Medical Systems, Inc.	FOZ	Class II	1988-04-19
K875297	James Tendos (Syringe Holder)	Med-Text Intl.	FMF	Class II	1988-04-19
K872520	Ss-1000 Polygraph	Meramed Corp.	DQA	Class II	1988-04-19
K870874	Cspi Specimen Trap (Non-Sterile)	Custom Surgical Products, Inc.	GCX	Class II	1988-04-19
K881579	Amies Transport Medium W/o Charcoal	Neogen Culture Media	JSN	Class I	1988-04-18
K881578	Streptosel	Neogen Culture Media	JSJ	Class I	1988-04-18
K881577	Modified Selective Streptococcus Agar	Neogen Culture Media	JSI	Class I	1988-04-18
K881576	Selenite Broth	Neogen Culture Media	JSI	Class I	1988-04-18
K881575	Selective Streptococcus Agar	Neogen Culture Media	JSI	Class I	1988-04-18
K881574	W-L Differential Medium	Neogen Culture Media	JSJ	Class I	1988-04-18
K881573	Phytone Yeast Extract Agar	Neogen Culture Media	JSJ	Class I	1988-04-18