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 2732 of 3530

510(k) clearances, page 2732 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880871	Grabber Warm Pack/mini Mini Heater/foot Heater	John Wagner Associates, Inc.	IMD	Class I	1988-05-20
K880720	Montgomery Nerve Stimulator	Boston Medical Products, Inc.	ETN	Class II	1988-05-20
K880506	Modified Eva-Mix and Di-Mix Bags	Gil-Med Industries C/O Kegan & Kegan, Ltd.	KPE	Class II	1988-05-20
K880306	Emergency-Clean Up(tm) Ecp	Cdc Products Corp.	EXB	Class I	1988-05-20
K875332	Ivac Volumetric Pump - Model 590	Y	FRN	Class II	1988-05-20
K874850	Epi-Scan Selective Tissue Conductance Meter	Epi-Scan Corp.	GZO	Class II	1988-05-20
K874505	Contain(tm)	Arbor Technologies, Inc.	GCX	Class II	1988-05-20
K874377	Anatomic Adjustable Axial Fixator Assembly	Harrington Arthritis Research Center	LXT	Class II	1988-05-20
K871442	Biosound Mmi Ultrasound	Biosound, Inc.	JOP	Class II	1988-05-20
K881951	Ride-Lite 9000 Series Wheelchair	Invacare GmbH	IOR	Class I	1988-05-19
K881356	External Pacemaker Wire Dressing Change	Neal & Assoc., Inc.	LDF	Class II	1988-05-19
K881313	Iqk-200	Medical Repackers Co.	BTR	Class II	1988-05-19
K881910	Labeling Change to Surgical Face Mask	Louis M. Gerson Co., Inc.	FXX	Class II	1988-05-18
K881873	Introduction/drainage Catheter & Access	Sheridan Catheter Corp.	GBS	Class I	1988-05-18
K881732	Gore-Tex Vascular Graft	W. L. Gore & Associates, Inc.	DYF	Class II	1988-05-18
K881688	Dtv-4114 Fluoroscopic Television Camera	Philips North America LLC	IZJ	Class II	1988-05-18
K881501	Modified Ids Rapid Nh System	Innovative Diagnostic Systems, Inc.	JSX	Class I	1988-05-18
K881328	Model 375 ECG	Birtcher Corp.	DPS	Class II	1988-05-18
K881281	Coag-a-Mate(r) Xm	bioMerieux, Inc.	GKP	Class II	1988-05-18
K881279	Edwards-Duromedics Bileaflet Valve Sizer Set	Baxter Healthcare Corporation	DTI	Class I	1988-05-18
K881193	Accutone in-the-Ear Hearing Aid	Interstate Hearing Aid Service	ESD	Class I	1988-05-18
K881143	Impulse Tvc (Richards, Omni, Marcon)	Richards Medical Co., Inc.	ESD	Class I	1988-05-18
K881136	Hewlett-Packard Models 78354A & 78352A Pulse Oxi.	Hewlett-Packard Co.	DQA	Class II	1988-05-18
K881003	Digital Blood Pressure Monitor Model Cx-1	Healthcheck Corp.	DXN	Class II	1988-05-18
K880774	Spectrum	Dentsply Intl.	ELL	Class II	1988-05-18
K880167	Gore-Tex Vascular Graft	W. L. Gore & Associates, Inc.	DSY	Class II	1988-05-18
K875370	Shimadzu Whole Body X-Ray CT Scanner Sct-3000Tx	Shimadzu Precision Instruments, Inc.	JAK	Class II	1988-05-18
K875036	Intra-Aortic Balloon Pump Model Kaat	Kontron Instruments, Inc.	DSP	Class II	1988-05-18
K874396	Oco Preparations	Williams Importing Company, Inc.	EJF	Class I	1988-05-18
K881766	Rem 250 Three Wheeled Electric Cart	Royal Enterprises Manufacturing, Inc.	INI	Class II	1988-05-17
K881643	Battery Packs for Cardiovascular Units	Dowit Service Co., Inc.	MHX	Class II	1988-05-17
K881634	Simplicity Series 5	Quartet Technology, Inc.	IQA	Class II	1988-05-17
K881308	Breath-Easy	Icor AB	BYD	Class I	1988-05-17
K881300	Magnesium Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	JGJ	Class I	1988-05-17
K880163	Pregnancy (Hcg) Card & Liquid Test	Ampcor, Inc.	JHJ	Class II	1988-05-17
K881379	Wesblot Rnp-Sm Test	American Bionetics, Inc.	LKP	Class II	1988-05-16
K881366	Biotrol Bun Enzymatique UV H.p.	Biotrol, USA, Inc.	CDQ	Class II	1988-05-16
K881338	Condom-Mate Vaginal Lubricant	Upsher-Smith Laboratories, Inc.	KMJ	Class I	1988-05-16
K881275	Uriqual(tm) Urinalysis Controls (Human) I & II	Fisher Scientific Company L.L.C.	JJY	Class I	1988-05-16
K881267	Biotrol Ck Monoeactif	Biotrol, USA, Inc.	JHX	Class II	1988-05-16
K881255	Nova 12 Na/k/c1/total Carbon Dioxide/glucose/urea	Nova Biomedical Corporation	JGS	Class II	1988-05-16
K881208	Probe Sheath for Adms Ultrasound Probe	Advanced Diagnostic Medical Systems, Inc.	IYO	Class II	1988-05-16
K881201	Hr Vacutrac	Abbott Medical	JKA	Class II	1988-05-16
K881197	Softrac-Pta(tm) Peripheral Dilatation Catheter	Schneider-Shilley (USA)	LIT	Class II	1988-05-16
K880927	Vascu-Care Angioscope	Vascu-Care, Inc.	DQX	Class II	1988-05-16
K880899	Pharmacia Igg Rast Ria/pharmacia Igg Rast Eia	Pharmacia, Inc.	DHB	Class II	1988-05-16
K880848	Fuji Cap II Capsule & Applier	G-C Intl. Corp.	EMA	Class II	1988-05-16
K880472	Advance* and Daisy* Pregnancy Test	Advanced Care Products	LCX	Class II	1988-05-16
K880442	Brushrite	Pro Care Laboratories, Inc.	JEG	Class II	1988-05-16
K875118	Peripheral Vascular Laboratory Assistant Model 101	Bloodflow Laboratory, Inc.	JOM	Class II	1988-05-16