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 2072 of 3531

510(k) clearances, page 2072 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K950933	Hollister Hydrocolloid Wound Dressings	Hollister, Inc.	FRO	Unclassified	1995-07-11
K950875	Ogden Anchor	American Medical Electronics, Inc.	HWC	Class II	1995-07-11
K950579	Micro-Vent Implant	Core-Vent Corp.	DZE	Class II	1995-07-11
K950578	Screw-Vent Implant	Core-Vent Corp.	DZE	Class II	1995-07-11
K950577	Swede-Vent Implant	Core-Vent Corp.	DZE	Class II	1995-07-11
K950576	Bio-Vent X Implant	Core-Vent Corp.	DZE	Class II	1995-07-11
K950575	Bio-Vent Implant	Core-Vent Corp.	DZE	Class II	1995-07-11
K946347	Absorbable Acetabular Screw	Zimmer GmbH	HWC	Class II	1995-07-11
K946274	Columnmate II Ghb Affinity Regenerable Column	Helena Laboratories, Corp.	LCP	Class II	1995-07-11
K946150	Cruciate Retaining (Augmentable) and Constrained Condylar Knee (Cck)	Zimmer GmbH	JWH	Class II	1995-07-11
K946054	Diplomax	Optical Micro Systems, Inc.	HQC	Class II	1995-07-11
K945843	Safety Plus	Arent Fox	EJI	Class II	1995-07-11
K945525	Anspach Suture Anchor	The Anspach Effort, Inc.	HWC	Class II	1995-07-11
K942432	J.b.s. Cervical Spine System	J.B.S., S.A.	KWP	Class II	1995-07-11
K942263	Miller/galante Precoat Unicompartmental Knee System	Zimmer GmbH	HSX	Class II	1995-07-11
K935263	Foundation Porous Stem	Encore Orthopedics, Inc.	JDI	Class II	1995-07-11
K934628	Cusa(r) Syst 200Ct/200t Ultra Aspir Lap/cem Access	Medtronic, Inc.	LFL	Unclassified	1995-07-11
K932453	Visuwell Syphilis Antibody	Biomira Diagnostics, Inc.	LIP	Class II	1995-07-11
K952678	Sta-Clear Alcohol-Free Endoscopic Anti-Fog Kit	Avail-Southwest Division	KDG	Class I	1995-07-10
K952578	Welch Ally Otoscope	Welch Allyn Inc	ERA	Class I	1995-07-10
K951829	Cold Light Source Los 150	Laser-Optik-Systeme GmbH & Co. KG	EQH	Class I	1995-07-10
K950833	Depuy Set Screw	Depuy, Inc.	HWC	Class II	1995-07-10
K946289	Devons Point Lok Needle Protection Device	Devon Industries, Inc.	FMI	Class II	1995-07-10
K945942	Auto Syringe(r) As50 Infusion Pump	Baxter Healthcare Corporation	FRN	Class II	1995-07-10
K945934	Uresil(r) Guidewire	Uresil, LLC	DQX	Class II	1995-07-10
K943765	Sharps Away	Biomedical Waste Systems, Inc.	FMI	Class II	1995-07-10
K943226	Buffalo Filter Replacement Filter #Bspf030	Buffalo Filter Co., Inc.	FYD	Class II	1995-07-10
K942930	Capcard	Capcard, Inc.	FMI	Class II	1995-07-10
K952428	Porous Media Dbf23-R Reusable Respiratory Filter	Pentair Filtration Solutions	CAH	Class II	1995-07-07
K952351	Precise Denture Base Resin	Dentsply Intl.	EBI	Class II	1995-07-07
K951879	Ticarcillin/clavulanic Acid 2	Ab Biodisk	JWY	Class II	1995-07-07
K951812	Modified Coherent Ultrapulse CO2 Surgical Lasers	Lumenis Ltd	GEX	Class II	1995-07-07
K950485	Graphic Controls Protrace ECG Electrode	Graphic Controls Corp.	DRX	Class II	1995-07-07
K946322	Polygram Software	Synectics Medical, Inc.	BZG	Class II	1995-07-07
K945479	Medi-Trace(r) 500 ECG Electrode	Graphic Controls Corp.	DRX	Class II	1995-07-07
K944787	Integrated Movement Analyzer	Maryrose	IKN	Class II	1995-07-07
K944451	Passy-Muir Tracheostomy Speaking Valves (One-Way Tracheostomy Speaking Valves)	Passy-Muir, Inc.	JOH	Class II	1995-07-07
K944260	ECG Electrode	Msb, Ltd.	DRX	Class II	1995-07-07
K944052	Rascal-II Respiratory and Anesthetic Gas Monitor	GE Healthcare	CCK	Class II	1995-07-07
K943227	Buffalo Filter Replacement Filter #Bsucf03	Buffalo Filter Co., Inc.	FYD	Class II	1995-07-07
K942989	Ocr II & Ocm II	Chambermaid Products Co.	FLE	Class II	1995-07-07
K952701	Med-Tron Spect Imaging Table	Med-Tron Products, Inc.	IZZ	Class II	1995-07-06
K952641	Quickie Tsr	Sunrise Medical, Inc.	IOR	Class I	1995-07-06
K952537	Therex Low Profile Titanium Model 1.0Mm I.d./1.8mm O.d.	Therex Corp.	LJT	Class II	1995-07-06
K952477	Stat Profile Ultra Blood Gas Controls	Nova Biomedical Corporation	JJS	Class I	1995-07-06
K952452	Output Compression Limiter with Active Tone Control	Argosy Electronics	ESD	Class I	1995-07-06
K952451	Class D Linear with Active Tone Control	Argosy Electronics	ESD	Class I	1995-07-06
K952450	Wide Dynamic Range Compression with Active Tone Control	Argosy Electronics	ESD	Class I	1995-07-06
K952408	Ati Disposable Test Pack for Steam Sterilization	Pymah Corp.	JOJ	Class II	1995-07-06
K952357	The Hill Adjustable Podiatry Model	Hill Laboratories	INQ	Class I	1995-07-06