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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2318 of 3531

510(k) clearances, page 2318 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924860	Aia-Pack Afp Calibration Verification Test Set	Tosoh Medics, Inc.	JJX	Class I	1993-03-04
K924575	Atlantis Gui	Hospitronics	MHX	Class II	1993-03-04
K924030	Scribe	Zygo Industries, Inc.	ILQ	Class II	1993-03-04
K924015	Parrot	Zygo Industries, Inc.	ILQ	Class II	1993-03-04
K924014	Secretary	Zygo Industries, Inc.	ILQ	Class II	1993-03-04
K924013	Macaw	Zygo Industries, Inc.	ILQ	Class II	1993-03-04
K923958	Chromos Imager	Chromos Imaging, Inc.	HKI	Class II	1993-03-04
K923861	Luhr Pan Fixation System	Howmedica Corp.	HRS	Class II	1993-03-04
K923533	Admark	Planmeca U.S.A. Inc	JAC	Class I	1993-03-04
K923501	High Volt Unit	Willows Health Center	IPF	Class II	1993-03-04
K923498	Biphasic Unit	Willows Health Center	IPF	Class II	1993-03-04
K923428	Panda	Etac Us, Inc.	IOR	Class I	1993-03-04
K923094	Molybdenum	Southeastern Medical Diagnostics, Inc.	ITY	Class I	1993-03-04
K922817	Pm3000 & Pm3100 Vacuum Regulator	Precision Medical, Inc.	KDP	Class II	1993-03-04
K922282	Illuminator VIII Ultra/spot	Medical Illumination, Inc.	KZF	Class I	1993-03-04
K922278	Illuminator III	Medical Illumination, Inc.	KZF	Class I	1993-03-04
K921287	Surgical Retractor	Advanced Surgical, Inc.	GCJ	Class II	1993-03-04
K920939	Dynatron 300 Ulrasound	Dynatronics Laser Corp.	IMG	Class II	1993-03-04
K920823	Welter Snare Retriever	Cook Inc.	DXE	Class II	1993-03-04
K915798	Psk Posterior Stabilized Toatal Knee	Implantology Corp.	JWH	Class II	1993-03-04
K915607	Patient Examination Gloves	Seal Polymer Industries Bhd.	LYY	Class I	1993-03-04
K930541	Voicemode, Ite, Air-Conduction Hearing Aid	Personal Sound Technologies, Inc.	ESD	Class I	1993-03-03
K930179	Tracheal Tube Fixation Device	Garrett Medical Products	BTR	Class II	1993-03-03
K930005	Dritrainer	Abbott Medical	KPN	Class II	1993-03-03
K925401	IV Fluid Transfer Pin	B. Braun of America, Inc.	LHI	Class II	1993-03-03
K925250	Kotex(r) Securehold Super Curve/curved Maxi Pads	Kimberly-Clark Corporation	HHD	Class I	1993-03-03
K924959	Sterling Latex Exam Glove, Hypo-Allergenic	Perlink USA, Inc.	LYY	Class I	1993-03-03
K924480	Cholangiography Clamp	Applied Medical Resources Corp	GBZ	Class I	1993-03-03
K923820	Laparoscopic Surgical Instruments	Microcut, Inc.	GCJ	Class II	1993-03-03
K922552	Morse(r) Angiographic Catheters	North American Instrument Corp.	DQO	Class II	1993-03-03
K922059	Disposable Cystoscopy Splash Drape-Sterile #599	Graham Medical Products	KKX	Class II	1993-03-03
K921765	Primedic Defibrillators-N/b	Metronic Electronic GmbH	LDD	Class II	1993-03-03
K920346	Various Utility/surgical Drape, Sterile, Disposabl	Trinity Laboratories, Inc.	KKX	Class II	1993-03-03
K926409	Plasma Discard Bags	Apheresis Technologies, Inc.	LKN	Unclassified	1993-03-02
K925961	Optima Archival and Retrieval System	Diagnostic Archives, Inc.	IZI	Class II	1993-03-02
K925680	Lsi System IV Interferential,muscle Stimulator	M.S.P., Ltd.	IPF	Class II	1993-03-02
K922488	Phasis Electromyograph	Biosound, Inc.	IKN	Class II	1993-03-02
K920445	Siemens Sirecust Penta System and Accessories	Siemens Medical Electronics	MHX	Class II	1993-03-02
K915174	Jms Apheresis Needle	JMS Co., Ltd.	FIE	Class II	1993-03-02
K914432	Accumeter(r) Cholesterol Self-Test	Chemtrak, Inc.	CHH	Class I	1993-03-02
K930318	Beltone Opera Lor, Itc	Beltone Electronics Corp.	ESD	Class I	1993-03-01
K930310	Beltone Optima 2000 Clearvoice Series, in-the-Ear	Beltone Electronics Corp.	ESD	Class I	1993-03-01
K925988	Multifibren	Behring Diagnostics, Inc.	KQJ	Class II	1993-03-01
K925824	Solos Fan Retractors	Birtcher Medical Systems, Inc.	GCJ	Class II	1993-03-01
K925649	Nat. Screening Institute Micro-Plate Free T4 Assay	Solarcare Technologies Corp,Inc.	CEC	Class II	1993-03-01
K925637	Access Htsh Assay	Bio-Rad Laboratories Inc.	JLW	Class II	1993-03-01
K925256	Quantimetrix Urinalysis Microscopics Control	Quantimetrix Corp.	JJY	Class I	1993-03-01
K925074	Usci Lumisilk Guide Wire with Pro/pel Coating	C.R. Bard Inc	DQX	Class II	1993-03-01
K924364	Vacuplus Tubes with Grey Stoppers	Starplex Scientific Corp.	JKA	Class II	1993-03-01
K924362	Vacuplus Tubes with Lavander Stoppers	Starplex Scientific Corp.	JKA	Class II	1993-03-01