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 2729 of 3530

510(k) clearances, page 2729 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882180	Modified Sharplan Model 1020 CO2 Laser	Sharplan Lasers, Inc.	GEX	Class II	1988-06-02
K881995	Diamond's Medium Modified	Remel Inc	KZI	Class I	1988-06-02
K881436	Sodium/potassium Serum Range Linearity Standards	Hichem Diagnostics	JJY	Class I	1988-06-02
K881064	Hygeia Gc Test	Hygeia Sciences	LIR	Class II	1988-06-02
K880879	Workstation Plus W/local Area Network(lan) Option	Ppg Industries, Inc.	DQK	Class II	1988-06-02
K875232	Intro-Reducer (Nasogastric Tube)	Health Improvement Assoc.	KNT	Class II	1988-06-02
K874892	Vitalograph-Ec60 Hydrogen Monitor	Vitalograph, Inc.	NRH	Class I	1988-06-02
K882004	Audina	American Audio Services, Inc.	ESD	Class I	1988-06-01
K881900	Perma-Pic Plastic Toothpick	The Perma-Pic Co.	JET	Class I	1988-06-01
K881861	Ptm-45	J.F. Jelenko & Co., Inc.	EJT	Class II	1988-06-01
K881860	Olympia II	J.F. Jelenko & Co., Inc.	EJT	Class II	1988-06-01
K881821	Sterile Surgical Latex Glove	Nca Med Intl./Noble House, Inc.	KGO	Class I	1988-06-01
K881809	Rep Lipo Kit Cat. No 3180	Helena Laboratories, Corp.	JHO	Class I	1988-06-01
K881789	Miniline Bracket	Alexotek Co.	EJF	Class I	1988-06-01
K881756	Sterile Surgeons Gloves	Packaging Technologies, Inc.	KGO	Class I	1988-06-01
K881612	Dahlberg Model Xj 8080 Body-Worn Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1988-06-01
K881607	Easy-Test Emit(r) Ethosuximide (Eths) Item 16647	Em Diagnostic Systems, Inc.	DLF	Class II	1988-06-01
K881498	Synchron Cx(tm)4 Clinical Analyzer	Beckman Instruments, Inc.	JJE	Class I	1988-06-01
K881495	Synchron Cx(tm)5 Clinical Analyzer	Beckman Instruments, Inc.	JJE	Class I	1988-06-01
K881474	Vision(r) Ldh (Lactate Dehydrogenase)	Abbott Medical	CFJ	Class II	1988-06-01
K881351	Imack-Mb, Catalogs 602-1, 602-1/125, 602-1/225	Intl. Immunoassay Laboratories, Inc.	JHY	Class II	1988-06-01
K881224	Acufex Suture Retriever, Sterile Disposable	Acufex Microsurgical, Inc.	GAE	Class I	1988-06-01
K881194	Ria-Quick	Quantitative Technologies, Inc.	JQP	Class I	1988-06-01
K881185	Annular Array Probes for Artis 3200 Diag. Ultra.	Philips North America LLC	HEM	Class II	1988-06-01
K881026	Contac, a Dentin Sealant	Harry J. Bosworth Co.	LBH	Class II	1988-06-01
K880988	Pudendal/local Anestesia Block Tray	BD Becton Dickinson Vacutainer Systems Preanalytic	KNE	Class II	1988-06-01
K880900	Ssd-620 Linear/convex Array Sector Scanner	Corometrics Medical Systems, Inc.	HEM	Class II	1988-06-01
K880591	Laseguide 600A, 600B, 400A, 400B for Ob-Gyn Use	Laser Peripherals LLC	HHR	Class II	1988-06-01
K880446	Safeskin Sterile Surgeons Gloves	Safeskin Corp.	KGO	Class I	1988-06-01
K880329	Factor II Prosthetic Silicone Elastomer	Factor, II, Inc.	GBI	Class I	1988-06-01
K880251	Kerr Xr Ionomer	Kerr Corporation (Danbury)	EMA	Class II	1988-06-01
K880250	Kerr Xr Bond	Kerr Corporation (Danbury)	EMA	Class II	1988-06-01
K874138	Accucom 2	Datascope Corp.	DPT	Class II	1988-06-01
K874018	Neuroprobe	Inovx, Inc.	ETN	Class II	1988-06-01
K873214	Apx Cardio Echocardiography System #H4300	General Electric Co.	DPT	Class II	1988-06-01
K882019	Sms 90-15 r&f Table and Sms 14 Spot Film Device	General Electric Co.	IXR	Class II	1988-05-31
K881965	Msi 5000 Series Bed	Med Service, Inc.	FNL	Class II	1988-05-31
K881803	Uvmax Kinetic Microplate Reader	Molecular Devices Corp.	JJQ	Class I	1988-05-31
K881785	N.s. Cadee	First Scientific, Div.	FMI	Class II	1988-05-31
K881770	Epicardia Le/fd	Medicomp, Inc.	DQK	Class II	1988-05-31
K881521	Modified Servo Syringe	Engineering, Inc.	DXT	Class II	1988-05-31
K881496	Linder Nasotracheal Airway	Polamedco, Inc.	BTR	Class II	1988-05-31
K881418	Craniotome Blade or Neuro Blade	Nuell Air Equipment & Hospital Supplies, Inc.	HBE	Class II	1988-05-31
K881392	Cardicad(tm)	Medical/Surgical Specialties, Ltd.	DWS	Class I	1988-05-31
K881265	Raney Clips	Zimmer GmbH	HBO	Class II	1988-05-31
K881239	Gamma Glutamyl Transferase Reagent Set	Tech-Neal Scientific, Inc.	JPZ	Class I	1988-05-31
K881088	Addition of a Tip Guard to the Atherocath(tm)	Devices for Vascular Intervention, Inc.	LIT	Class II	1988-05-31
K881074	Shiley Femoral Venous Cannula	Shiley, Inc.	DWF	Class II	1988-05-31
K881072	Shiley Femoral Arterial Cannula	Shiley, Inc.	DWF	Class II	1988-05-31
K880930	Mdls 4000,4900,6000,8000,8900 Nd:yag/1700 C02 Lase	Copper Lasersonics, Inc.	HHR	Class II	1988-05-31