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 2697 of 3530

510(k) clearances, page 2697 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882001	Diacare Monitoring System	Healthware Corp.	NDC	Class II	1988-10-18
K874416	Dental Anti-Snoring Device	Ortho Publications, Inc.	LRK	Class II	1988-10-18
K884212	Winged Non-Coring Needle Set	Marquette Medical, Inc.	FMI	Class II	1988-10-17
K884211	Straight and Right Angle Non-Coring Needles	Marquette Medical, Inc.	FMI	Class II	1988-10-17
K884023	Maestro(r) Series 100/200 Single Chamber Pacemaker	Cardiac Control Systems, Inc.	DXY	Class III	1988-10-17
K883955	Single-Fil(tm) Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1988-10-17
K883819	Bullard Intubating Laryngoscope Lar-a & Lar-P	Circon Acmi	CCW	Class I	1988-10-17
K883436	Ppg Biomedical Flexible Micro Transducer Catheter	Ppg Industries, Inc.	DXO	Class II	1988-10-17
K883410	Cardiomega-T	Grandcor Medical Systems	DSI	Class II	1988-10-17
K881915	Dantec Magnetic Stimulator	Dantec Electronics, Inc.	GWF	Class II	1988-10-17
K884024	Polysafe(tm) Implantable Pacing Lead	Cardiac Control Systems, Inc.	DTB	Class III	1988-10-14
K883775	Portable II Dental Delivery System	Dntl Corp.	EIA	Class I	1988-10-14
K883452	Acs Indeflator P/t 20	Advanced Cardiovascular Systems, Inc.	DXT	Class II	1988-10-14
K883265	Model 329-701 Bipolar Active-Fixation Lead	Telectronics and Cordis Pacing Systems	DTB	Class III	1988-10-14
K883174	Multi-Med Infusion Catheter and Kit Double/triple	Baxter Healthcare Corporation	DQY	Class II	1988-10-14
K883091	Sharplan 4300 & 4310 Ultrasonic Surgical Apirators	Sharplan Lasers, Inc.	LFL	Unclassified	1988-10-14
K883003	Multi-Drug Infusion System	Halyard Health	FRN	Class II	1988-10-14
K882869	Townley Cox Comb Acetabular Component	Biopro, Inc.	JDI	Class II	1988-10-14
K882607	Ultraflotation Bed	Medical Flotation Systems, Inc.	IOQ	Class II	1988-10-14
K881799	Blood Pressure Cuff	Biomedical Dynamics, Inc.	DXQ	Class II	1988-10-14
K881456	Pipelle De Cornier Endometrial Suction Curette	Laboratoire Ccd C/O Washington Regulatory Services	HHK	Class II	1988-10-14
K881291	Air Plethysmograph Model Apg-1000	Aci Medical, LLC	DSB	Class II	1988-10-14
K884112	Caretex or Towel	James River Corp.	KKX	Class II	1988-10-13
K884110	Ltdt Patient Lifter	Devine Medical Products	ILK	Class II	1988-10-13
K884092	Surgilase CO2 Surgical Laser System Model Sl80	Surgilase, Inc.	GEX	Class II	1988-10-13
K884073	Laryngoscope Blade (Robertshaw Style)	Eastmed Enterprises, Inc.	CCW	Class I	1988-10-13
K884055	Surgi-Tag(tm) Sterile Label Sets	Acacia Laboratories, Inc.	LYV	Class I	1988-10-13
K884039	Medical Dynamics Solid State Video Camera 5940	Medical Dynamics, Inc.	FWH	Class I	1988-10-13
K884032	Morgan Transcutaneous Electrical Nerve Stimulator	Morgan Associates, Inc.	GZJ	Class II	1988-10-13
K884019	Alm Operating Tables	Alm Surgical Equipment, Inc.	FWX	Class I	1988-10-13
K883946	Vision Creatine Kinase	Abbott Medical	CGS	Class II	1988-10-13
K883927	Ciba Corning Magic Lite Hcg Immunoassay	Ciba Corning Diagnostics Corp.	JHI	Class II	1988-10-13
K883921	Omnifit Threaded Acetabular Comp. W/micro Coating	Osteonics Corp.	LWJ	Class II	1988-10-13
K883861	Document(tm) Protein/cholesterol Linearity Test	Casco Standards	JJY	Class I	1988-10-13
K883824	Sterile Surgical Latex Gloves	Intl. Trading Ventures, Inc.	KGO	Class I	1988-10-13
K883737	Vfq Head Coil	Resonex, Inc.	LNH	Class II	1988-10-13
K883659	Hle-1000 High/low Treatment Table	Rich-Mar Corp.	INQ	Class I	1988-10-13
K883654	Steri-Tag(tm) Sterile Label Sets	Acacia Laboratories, Inc.	LYV	Class I	1988-10-13
K883439	Intersept*crystalloid Cardioplegia Delivery System	Medtronic Blood Systems, Inc.	DTR	Class II	1988-10-13
K883435	Novaspec II Spectrophotometer	Pharmacia, Inc.	JJQ	Class I	1988-10-13
K883387	Alanine Amino Transferase (Colorimetric Method)	Tech-Co, Inc.	CKD	Class I	1988-10-13
K883361	Arthro-Trac(tm)	Rudolph Beaver, Inc.	HRX	Class II	1988-10-13
K883358	Telescan Instant Memory ECG Recorder Model T-35Cm	Telescan Medical Systems	DXH	Class II	1988-10-13
K883326	Technicon Ra(tm) Systems - Magnesium	Technicon Instruments Corp.	JGJ	Class I	1988-10-13
K883296	Laryngoscope	Lothar Scharras	CCW	Class I	1988-10-13
K883270	Iris Nd:yag Opthalmic Laser	California Laboratories, Inc.	LQJ	Class II	1988-10-13
K883221	Pti Intra-Art Inter Mamm Artery Papaver Infus Kit	Pioneering Technologies, Inc.	DWF	Class II	1988-10-13
K883152	Ep-Stat	Coherent Systems, Inc.	DQK	Class II	1988-10-13
K883092	Bennett Bca-6 &Bca-9 Mobile C-Arm Unit/radio/flour	Bennett X-Ray Corp.	IZL	Class II	1988-10-13
K883082	Pleur-Evac(r)-a-7020-Infant Chest Drain System	Deknatel, Inc.	CAC	Class II	1988-10-13