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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3145 of 3528

510(k) clearances, page 3145 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832034	Emit Aad Theophylline Assay	Syva Co.	KLS	Class II	1983-08-01
K832033	Emit AED Phenytoin Assay	Syva Co.	DIP	Class II	1983-08-01
K832010	Broncho-Fiberscope	Karl Storz Endoscopy-America, Inc.	EOQ	Class II	1983-08-01
K832006	Pentax Fd-34A Duodenofiberscope	Pentax Precision Instrument Corp.	FDT	Class II	1983-08-01
K831950	Pulsar #B Single Channel TENS-Pulsar D	Spembly Medical, Ltd.	GZJ	Class II	1983-08-01
K831837	Clinovative II Diagnostic Kit	Pierce Chemical Co.	LCP	Class II	1983-08-01
K831644	Pipette 12 Channel	bioMerieux, Inc.	JTC	Class I	1983-08-01
K831949	Prosthetic Rings #4400 Mitral & 4500	American Edwards Laboratories	KRH	Class II	1983-07-29
K831948	Lkb 2161 Midispin R Centrifuge	Lkb Instruments, Inc.	JQC	Class I	1983-07-29
K831947	Lkb 2160 Midispin Centrifuge	Lkb Instruments, Inc.	JQC	Class I	1983-07-29
K831942	Lkb 2164 Macro-Spin R Centrifuge	Lkb Instruments, Inc.	JQC	Class I	1983-07-29
K831922	Embedding Ring	Polymer Technology Corp.	KER	Class I	1983-07-29
K831921	Disposable Microtome Blades	Polymer Technology Corp.	IDL	Class I	1983-07-29
K822856	Vitaline 2	American Heartline, Inc.			1983-07-29
K831900	Maclean-Fogg, Disp. Base Mold	Polymer Technology Corp.	KER	Class I	1983-07-28
K831896	Compact Four	Nicolet Biomedical Instruments	GWF	Class II	1983-07-28
K831871	Sickle-Heme a/s Controls & A/a Control	Anco Medical Reagents & Assoc.	GHM	Class II	1983-07-28
K831866	Model Dms 100 Ultraviolet-Visible Spec	Varian Assoc., Inc.	JJQ	Class I	1983-07-28
K831855	Hatch Kit	Radioassay Systems Laboratories, Inc.	CKG	Class II	1983-07-28
K831814	Calibration Standard-Hemoglobin	United Diagnostics, Inc.	KRZ	Class II	1983-07-28
K831813	Co-Oximeter Control	United Diagnostics, Inc.	KHG	Class II	1983-07-28
K831811	Revolution Radial Immunodiffusion Plate	Calbiochem-Behring Corp.	JZQ	Class I	1983-07-28
K831736	Tricyclic Antidepressants	Utak Laboratories Inc	DIF	Class I	1983-07-28
K831671	Modified Soybean Casein Digest Broth	Isle Media and Sterile Products, Inc.	JSG	Class I	1983-07-28
K831653	Lyophilized Microorganisms	Austin Biological Laboratories	JTR	Class I	1983-07-28
K831623	Dia Strips System	California Immuno Diagnostic, Inc.	CDM	Class I	1983-07-28
K831620	Sodium Hypochlorite 3%	Omega Medical Diagnostics	PPM	Class I	1983-07-28
K831619	Sodium Hypochlorite 7%	Omega Medical Diagnostics	PPM	Class I	1983-07-28
K831513	Kennedy Tibial Component	Zimmer GmbH	HSX	Class II	1983-07-28
K831484	Composi-Glaze	Denpac Corp.	EBF	Class II	1983-07-28
K831483	Save-a-Bake Porcelain Polish	Denpac Corp.	EIH	Class II	1983-07-28
K831453	Silcath Central Catheter Tray W/18 Ga	Argon Medical Corp.	JCY	Class I	1983-07-28
K831408	DNA Flor	Medastat Scientific Corp.	DHN	Class II	1983-07-28
K831379	Model 947 Video Blood Gas Sys	Avl Scientific Corp.	CHL	Class II	1983-07-28
K831313	Tissue-Tek V.i.p. 100/200	Miles Laboratories, Inc.	IEO	Class I	1983-07-28
K831249	Pro Quantum	Abbott Medical	JQW	Class I	1983-07-28
K831232	Lifestat 200	Physio Control, Inc.	DXN	Class II	1983-07-28
K831127	Intra-Oral Artificial Larynx	Xomed, Inc.	ESE	Class I	1983-07-28
K831001	Unicuff-Blood Pressure Cuff	Frontier Products	DXQ	Class II	1983-07-28
K830907	Ambulatory ECG Event Recorder	Brentwood Instruments, Inc.	DSH	Class II	1983-07-28
K830931	Portable Autoclaves	Arnold & Sons	FLE	Class II	1983-07-27
K832254	Baxa Addiseal	Baxa Corp., Sub. of Cook Group, Inc.	KPE	Class II	1983-07-26
K832247	i.v. Bag Addiseal	Baxa Corp., Sub. of Cook Group, Inc.	KPE	Class II	1983-07-26
K832214	Gauze Conversion Class I-Non-Sterile	Winn Hirsch & Assoc.	EFQ	Unclassified	1983-07-26
K832213	Gauze Conversion Class II Sterile	Winn Hirsch & Assoc.	EFQ	Unclassified	1983-07-26
K832194	Surgical Face Mask-Disposable	Tecnol New Jersey Wound Care, Inc.	FXX	Class II	1983-07-26
K832157	Delta Conductive Adhesive Electrosurg-	Delta Medical Electronics, Inc.	GEI	Class II	1983-07-26
K832147	Circut 1	Brimfield Scientific Instruments			1983-07-26
K832129	Hearing Aid G3h & G3t	Widex Hearing Aid Co., Inc.	ESD	Class I	1983-07-26
K832099	Medtronic Models 4012 & 4512	Medtronic, Inc.	DTB	Class III	1983-07-26