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 2722 of 3530

510(k) clearances, page 2722 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882233	Tdx (R) Digoxin Nxt	Abbott Medical	KXT	Class II	1988-07-06
K882029	Labeling for Revised Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	1988-07-06
K881733	Shiley Femoral Coronary Perfusion Catheter	Shiley, Inc.	DWF	Class II	1988-07-06
K881438	Urea/glucose/creatinine Serum Range Linearity Stan	Hichem Diagnostics	JJY	Class I	1988-07-06
K881437	Chloride/total CO2 Serum Range Linearity Standards	Hichem Diagnostics	JJY	Class I	1988-07-06
K872867	Biosign	Clinical Technology Inc.	FRC	Class II	1988-07-06
K882409	Pe100r Fm Receiver Used W/pe100t Fm Transmitter	Phonic Ear, Inc.	EPF	Class II	1988-07-05
K882243	Sptl-1 Pulsed Dye Laser	Candela Corporation	GEX	Class II	1988-07-05
K882150	Hearing Aid (All-in-the-Ear)	Clear-Tone Hearing Aid Center	ESD	Class I	1988-07-05
K882104	Ion Selective Electrode Subsystem of Para. Analyt.	Paramax Systems Div. Baxter Healthcare	JGS	Class II	1988-07-05
K881735	Condom	Iris Medical Ent., Inc.	HIS	Class II	1988-07-05
K881734	Shiley Femoral Left Ventricular Vent Catheter	Shiley, Inc.	DWF	Class II	1988-07-05
K881717	Pti Heart-Lift(tm) Cardiac Support Sling (Sterile)	Buckman Co., Inc.	DWS	Class I	1988-07-05
K881691	Preassembled Surgical Wash Set 122,175,225,375Aa	Shiley, Inc.	DWF	Class II	1988-07-05
K875182	Modified Labeling for Toxi-Lab Thc Screen	Marion Laboratories, Inc.	DKE	Class II	1988-07-05
K882575	Distometer	Hagg-Streit Service, Inc.	HMM	Class I	1988-07-01
K882495	Thioglycollate Broth W/vita. K & Hemin - #T3007	Lakewood Biochemical Co., Inc.	JSG	Class I	1988-07-01
K882343	Terumo Sensibead(tm) Eia Estradiol Kit	Terumo Medical Corp.	CHP	Class I	1988-07-01
K882294	Emit Convenience Pack: Tobramycin Assay	Syva Co.	KLB	Class II	1988-07-01
K882287	Canon Autorefractometer R-20	Canon Medical Components U.S.A., Inc.	HKO	Class I	1988-07-01
K882214	Simplastin Excel S	bioMerieux, Inc.	GJS	Class II	1988-07-01
K882191	Nidek Ark-2000	Nidek, Inc.	HKO	Class I	1988-07-01
K882189	Biotrol Total Protein H.p.	Biotrol, USA, Inc.	CEK	Class II	1988-07-01
K882149	Minifuge, Model 70	Utah Bioresearch, Inc.	GPG	Class I	1988-07-01
K882103	Site Ultrasonic I/a Phaco Needle	Site Microsurgical Systems, Inc.	HQC	Class II	1988-07-01
K882101	Hemoglobin Screening Device	Portable Medical Laboratories, Inc.	KSL	Class I	1988-07-01
K882081	Specific Chemistry Analyzer	The Rupp & Bowman Co.	JJE	Class I	1988-07-01
K881903	Prosthodent Vl	Lee Pharmaceuticals	EBF	Class II	1988-07-01
K881849	Bodai M.d.d. Adaptor(tm)	B & B Medical Technologies, Inc.	BZA	Class I	1988-07-01
K881832	Ds-200 and Ds-400 t.e.n.s.	Delta Marketing, Inc.	GZJ	Class II	1988-07-01
K881829	Pat Platelet Aggregation Test	Streck Laboratories, Inc.	JBX	Class II	1988-07-01
K881795	Shimadzu X-Ray High Voltage Generator Ud150k	Shimadzu Precision Instruments, Inc.	IZO	Class I	1988-07-01
K881682	Alcon Site(r)-Compatible Cassette	Alcon Laboratories	KYG	Class I	1988-07-01
K881635	Noetix(r) Surgical Extraction(tm) System	Noetix, Inc.	HQC	Class II	1988-07-01
K881231	Dabc Nonconductive Heated Anesth. Breath. Circuit	Intertech Resources, Inc.	BZE	Class II	1988-07-01
K881165	Sakura Hem-480 Electron Microscopy Processor	Sakura Finetek USA Inc	IEO	Class I	1988-07-01
K881113	Clp Lipoprotein Electrophoresis Control	Creative Laboratory Products, Inc.	JJY	Class I	1988-07-01
K881037	Spectrolyse/fibrin	Cytrx Biopool, Ltd.	GGP	Class II	1988-07-01
K880750	Nova Stat Profile 6 Analyzer + Quality Control Mat	Nova Biomedical Corporation	JGS	Class II	1988-07-01
K880741	Espe Varnish	Espe GmbH (US)	LBH	Class II	1988-07-01
K880543	Uni-Port	Surgeon Surgical Instrumentation, Inc.	KYG	Class I	1988-07-01
K880076	G-Mark	Bainbridge Laboratories, Inc.	LIC	Class II	1988-07-01
K875357	Biopsy Fixation Unit-Type Ua 0997	Bruel & Kjaer Industri A/S	IYO	Class II	1988-07-01
K875229	Dsl Somatomedin-C (Dsl #5600)	Diagnostic Systems Laboratories, Inc.	CFL	Class I	1988-07-01
K875198	Digital Nuclear Imaging System	Medasys, Inc.	IYX	Class I	1988-07-01
K874910	Shimadzu Digital Subtraction System Dar-200	Shimadzu Precision Instruments, Inc.	IZI	Class II	1988-07-01
K874236	Apollo Condom	Apollo Enterprise, Ltd. Co.	HIS	Class II	1988-07-01
K882443	Zindrick Im Rod Instruments	Buckman Co., Inc.	HSB	Class II	1988-06-30
K882434	Mask, Gas, Anesthetic	Eastmed Enterprises, Inc.	BSJ	Class I	1988-06-30
K882421	Infant Electrosurgical Dispersive Electrode	Dermacare Products, Inc.	JOS	Class II	1988-06-30