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 2664 of 3530

510(k) clearances, page 2664 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K890935	System 3000 Fluidized Air Bed	Dermanetics Corp.	IOQ	Class II	1989-03-15
K890888	Abuscreen Fp for Morphine	Roche Diagnostic Systems, Inc.	DJG	Class II	1989-03-15
K890883	Abuscreen Fp Buffer Reagent	Roche Diagnostic Systems, Inc.	DIO	Class II	1989-03-15
K890882	Abuscreen Fp for Phencyclidine	Roche Diagnostic Systems, Inc.	LCL	Unclassified	1989-03-15
K890647	Medilog 9000-II Ambulatory Recorder	Oxford Medilog, Inc.	DSH	Class II	1989-03-15
K890619	Edl Activated Partial Thromboplastin Time Reagent	Elite Diagnostic, Ltd.	GFO	Class II	1989-03-15
K890566	Berman Type Airway #59422-59429 Various Sizes	Medi-Source, Inc.	CAE	Class I	1989-03-15
K890524	Apec Glucose Analyzer	Amdev, Inc.	CGA	Class II	1989-03-15
K890470	Riatrac Plus	BD Becton Dickinson Vacutainer Systems Preanalytic	JJY	Class I	1989-03-15
K890414	Radioassay Controls 19,20,21,33,34 & 35 (Qas.109)	Amersham Corp.	JJY	Class I	1989-03-15
K890325	Usci Disp. Y-Connector W/modified Tuohy-Borst Adap	C.R. Bard Inc	LIT	Class II	1989-03-15
K890281	Human Lyme Eia for the Detect of Antibodies	Cambridge Bioscience Corp.	LSR	Class II	1989-03-15
K890201	Radiolucent ECG Electrode Model No: 1680	Medtronic, Inc.	DRX	Class II	1989-03-15
K890112	Engstrom Eliza + CO2 Analyzer	Gambro, Inc.	CCK	Class II	1989-03-15
K890086	Microlase 8 0 0 (Ophthalmic Laser)	Keeler Instruments, Inc.	HQF	Class II	1989-03-15
K890060	Ceramic Total Hip Ball Head, Large Taper	Depuy, Inc.	LZO	Class II	1989-03-15
K885338	Aml Bowed Femoral Hip	Depuy, Inc.	JDI	Class II	1989-03-15
K885298	Visuwell Reagin Test 960 Test Kit	Allelix Diagnostics, Inc.	GMP	Class II	1989-03-15
K885261	Arrow Micro Computer Control Switch & Environ. Sys	Invacare GmbH	ITI	Class II	1989-03-15
K885212	Arrow Micro Computer Control	Invacare GmbH	ITI	Class II	1989-03-15
K885182	Total Knee Cpm	Invacare GmbH	BXB	Class I	1989-03-15
K885137	Astro Trace (Model at-02)	The le Blanc Corp.	DSA	Class II	1989-03-15
K884840	B.a.c. 1000 Mobile Standing Device	Luconex, Inc.	IPL	Class II	1989-03-15
K884686	Vapamasta 5	Dentsply Intl.	CAD	Class II	1989-03-15
K884477	Shimadzu X-Ray High Voltage Generator Ud150b	Shimadzu Precision Instruments, Inc.	KPR	Class II	1989-03-15
K884028	Multi Camera Control Unit (Mccu)	Leybold-Inficon, Inc.	JAA	Class II	1989-03-15
K883767	Lyme Disease Ifa (Igm)	Hillcrest Biologicals	LSR	Class II	1989-03-15
K883411	Pg-Numeric(tm)	Isolab, Inc.	JHF	Class II	1989-03-15
K891103	Sterile Patient Examination Glove	Boston Medical Corp.	LYY	Class I	1989-03-14
K890924	Thermo-Pack	Medical Manufacturers	IMD	Class I	1989-03-14
K890923	Vitalon Matress Massage Model M-Mx	Nexus Co., Ltd. C/O Yama Trans Co., Ltd.	ISA	Class I	1989-03-14
K890878	Photomulitplier Tube Interface P.c. Board	U.S. Imaging, Inc.	JAA	Class II	1989-03-14
K890867	Tc System-Cover	Transmedical Corp.	FTA	Class II	1989-03-14
K890866	Tc System-Handle	Transmedical Corp.	FTA	Class II	1989-03-14
K890826	Sony Video Graphic Printer Up-850	Sony Corp. of America	KQM	Class I	1989-03-14
K890771	Aseptex 1812 Sub-Micron Molded Surgical Mask	3M Company	FXX	Class II	1989-03-14
K890770	Sterile Laparotomy Sponges	Cypress Medical Products LLC	EFQ	Unclassified	1989-03-14
K890745	Sc-1000 with Suffixes (Scan Converter)	Eigen	JAA	Class II	1989-03-14
K890710	Disposable Eeg/ekg Electrode, Cat. #Eeds	Somatics, LLC	GXY	Class II	1989-03-14
K890709	O.r. Towels (Sterile)	Cypress Medical Products LLC	KKX	Class II	1989-03-14
K890596	Med-a-Call Assist Device	Silent Call Corp.	IQA	Class II	1989-03-14
K890483	The Pathfinder System	Denmark Assoc.	IZH	Class II	1989-03-14
K890394	Medrad Scpd 1000	Medrad, Inc.	LNH	Class II	1989-03-14
K890362	Omnifilter Main Flow Bacteria Filter	Medtronic, Inc.	CAH	Class II	1989-03-14
K890341	Mick 200-Tp and Mick Tp Needle	Mick Radio-Nuclear Instruments, Inc.	IWJ	Class I	1989-03-14
K890272	Bag Decanter	Superior Medical Products	KPE	Class II	1989-03-14
K890193	Single Patient Use Nasal (CPAP) Circuit	Medtronic, Inc.	BYG	Class I	1989-03-14
K890003	Giardia Stool Antigen Test Kit	Lmd Laboratories	KHW	Class II	1989-03-14
K885270	Personal Transfer System	Columbus Mckinnon Corp.	FNG	Class II	1989-03-14
K885228	Rt6800 Echocardiography System	General Electric Co.	IYO	Class II	1989-03-14