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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2901 of 3529

510(k) clearances, page 2901 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860935	Emds Amylase (Amyl) Test Packs, # 67653/95	Em Diagnostic Systems, Inc.	CIJ	Class II	1986-05-23
K860773	Toxoplasma Igg Clin-Elisa Test Kit Cat. No. 4560	Clinical Sciences, Inc.	LGD	Class II	1986-05-23
K860721	Biotrack Protime Test Prothrombin Time Test	Biotrack, Inc.	GJS	Class II	1986-05-23
K860720	Biotrack Monitor (Biotrack Reagent Cartridges)	Biotrack, Inc.	JJQ	Class I	1986-05-23
K860719	Biotrack Protime Controls (Biotrack Protime Test)	Biotrack, Inc.	JPA	Class II	1986-05-23
K860234	Transvaginal Transducer, 5Mhz	Philips North America LLC	HGL	Class II	1986-05-23
K861839	Vapofil	Southmedic Inc.	CAD	Class II	1986-05-21
K861787	Biosil H	Degussa Dental, Inc.	EJH	Class II	1986-05-21
K861784	Medsurg Single Use Basin Set	Medsurg Industries, Inc.			1986-05-21
K861772	Laser Skin Marker and Mask White Lotion	Pacific Poly Crafts	FZZ	Class I	1986-05-21
K861740	P-50 Light Cured Resin Bonded Ceramic	3M Company	EBF	Class II	1986-05-21
K861583	CO2 Laser Bronchoscope System	Richard Wolf Medical Instruments Corp.	LLO	Class II	1986-05-21
K861561	Zest Mark II (Standard & Mini)	Zest Anchors LLC	EGG	Class I	1986-05-21
K861546	Replica-F Visible Light-Cured Ant/post Den Com Kit	Macrochem Corp.	EBF	Class II	1986-05-21
K861484	Infant Monitor	Healthdyne, Inc.	BZQ	Class II	1986-05-21
K861431	Therapax Ht 150T	Old Delft Corp. of America	JAD	Class II	1986-05-21
K861401	Laerdal Pocket Mask	Laerdal Medical a/S	CBP	Class II	1986-05-21
K861315	Hyperbaric Penetration Extension Set	Cutter Laboratories, Inc.	CBF	Class II	1986-05-21
K861096	Cardiopulmonary Cannula Tubing	Bio Medicus, Inc.	DWF	Class II	1986-05-21
K860988	Rmi Carotid by-Pass Shunt	Research Medical, Inc.	DWF	Class II	1986-05-21
K860980	Pc Arrhythmia Detection/analysis - Arrhythmia III	Spacelabs, Inc.	DSI	Class II	1986-05-21
K860920	Stockert-Shiley Heater/cooler Temperature Control	Shiley, Inc.	DTR	Class II	1986-05-21
K860843	Check-Up Plaque Fighting Gum	Minnetonka, Inc.	EJR	Class I	1986-05-21
K860692	Ptr Mk II Ventilator	Bear Medical Systems, Inc.	BYT	Class II	1986-05-21
K860373	The M100 Air/oxygen Mixer	Newport Medical Instruments, Inc.	BZR	Class II	1986-05-21
K853912	Microselection Interstitial Remote Afterload Sys	Nucletron-Oldelft Corp.	JAQ	Class II	1986-05-21
K861824	Gentamicin Sulfate Solution (10Mg Gentamicin)	Flow Laboratories, Inc.	JSK	Class I	1986-05-20
K861823	Gentamicin Sulfate Solution (50Mg Gentamicin)	Flow Laboratories, Inc.	JSK	Class I	1986-05-20
K861817	Horse Blood Cells in Alsevers Citrate/defibrinated	Hazleton Research Products, Inc.	KIS	Class I	1986-05-20
K861816	Mouse Blood Cells in Alsevers or Citrate	Hazleton Research Products, Inc.	KIS	Class I	1986-05-20
K861815	Bovine Blood Cells in Alsevers Citrate/defibrinate	Hazleton Research Products, Inc.	KIS	Class I	1986-05-20
K861814	Rhesus Monkey Serum - Sterile Filtered	Hazleton Research Products, Inc.	KIS	Class I	1986-05-20
K861813	Human Ab Serum - Sterile Filtered	Hazleton Research Products, Inc.	KIS	Class I	1986-05-20
K861812	Human Serum - Sterile Filtered	Hazleton Research Products, Inc.	KIS	Class I	1986-05-20
K861811	Mouse Serum - Sterile Filtered	Hazleton Research Products, Inc.	KIS	Class I	1986-05-20
K861810	Chicken Serum - Sterile Filtered	Hazleton Research Products, Inc.	KIS	Class I	1986-05-20
K861809	Lamb Serum - Sterile Filtered	Hazleton Research Products, Inc.	KIS	Class I	1986-05-20
K861791	Penicillin-Streptomycin-Fungizone	Flow Laboratories, Inc.	JSK	Class I	1986-05-20
K861774	Quadra-Titer (Tm) I.d. (Modification)	Microtech Medical Systems, Inc.	JSS	Class I	1986-05-20
K861437	Qmed System 2150	Qmed, Inc.	DXG	Class II	1986-05-20
K861272	Impact Models 701, 702 and 703	ZOLL Medical Corporation	BTL	Class II	1986-05-20
K861217	Vwf-Ix:ag Control Plasma	American Bioproducts Co.	GGP	Class II	1986-05-20
K861112	Model E2517 and Model E2503 Power Control Pencils	Medtronic, Inc.	GEI	Class II	1986-05-20
K861058	Sensititre Auto Id Plate, Ap70	Gibco Laboratories Life Technologies, Inc.	JTO	Class I	1986-05-20
K861007	Becton Dickinson Pcainfuser	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1986-05-20
K860621	1Mhz Cw Doppler Transducer W/lily Antepartum #507	Impex Medical Systems, Inc.	HGL	Class II	1986-05-20
K860493	Cytotech Cmv Igg Eia	Cytotech, Inc.	GQI	Class II	1986-05-20
K860307	Peel Away & Split Sheath Percu Cath Introducer Set	Teleflex Medical	DYB	Class II	1986-05-20
K860258	Teleflex Teflon Coated Guidewire	Teleflexmedical, Inc.	DQX	Class II	1986-05-20
K854902	Surgicot Steam Test Pack	Surgicot, Inc.	FRC	Class II	1986-05-20