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 2748 of 3530

510(k) clearances, page 2748 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K875350	Ohmeda Modulus II Plus Anesthesia System	GE Healthcare	BSZ	Class II	1988-03-24
K875334	Kontron Sigma 1 Digital Echocardiograph System	Kontron Instruments, Inc.	HGL	Class II	1988-03-24
K874887	Wesblot Processor	American Bionetics, Inc.	KPA	Class I	1988-03-24
K874875	Chemelia Free Thyroxine(ft4)/enzyme Immuno. (Eia)	Boots-Celltech Diagnostics, Inc.	CEC	Class II	1988-03-24
K874829	Medco Memory Retractor System	Medical Equipment Development Co., Inc.	GZT	Class II	1988-03-24
K873992	Laryngectomy Tube	Abbott Medical	KAC	Class I	1988-03-24
K873834	Inet Model Biovision	Inet Corp.	HCC	Class II	1988-03-24
K873825	Ge Lexan 144R 112	Applied Laboratories, Inc.	LRX	Class II	1988-03-24
K873824	Red #467, #457, Blue #437, Green #447 Mindel S1000	Applied Laboratories, Inc.	LRX	Class II	1988-03-24
K873823	Mobay (Bayer) Makrolon 2658 3291	Applied Laboratories, Inc.	LRX	Class II	1988-03-24
K873822	Mobay (Bayer) Merlon M-40 (h)f 1112	Applied Laboratories, Inc.	LRX	Class II	1988-03-24
K873821	Ge Noryl 731-80089S	Applied Laboratories, Inc.	LRX	Class II	1988-03-24
K873820	Mobay (Bayer) Makrolon 2658 1112	Applied Laboratories, Inc.	LRX	Class II	1988-03-24
K872998	Vitaaccess (Tm) Catheter Introducer System	Vitaphore Corp.	FOZ	Class II	1988-03-24
K881125	Pathfinder(tm) Chlamydia Eia Brush Collection Kit	Kallestad Diag, A Div. of Erbamont, Inc.	LIO	Class I	1988-03-23
K881068	Clp Activated Partial Thromboplastin Time Test	Creative Laboratory Products, Inc.	GFO	Class II	1988-03-23
K880629	Creatinine	Tech-Co, Inc.	CGX	Class II	1988-03-23
K880598	Modifications to Api Uniscept (R) Kb	Analytical Products, Inc.	JWY	Class II	1988-03-23
K880566	Clp Prothrombin Time Test	Creative Laboratory Products, Inc.	GJS	Class II	1988-03-23
K880330	Ferris Hydrophilic Dressing	Ferris Mfg. Corp.	FRO	Unclassified	1988-03-23
K880264	Bone Suture Fixation Device	Mizuho Orthopedic Systems Inc	HXY	Class I	1988-03-23
K875368	The Ddi Serodot Rubella Igg Test Kit	Disease Detection International, Inc.	LFX	Class II	1988-03-23
K875328	Ivt Western Allergy Screen	In Vitro Technologies, Inc.	DHB	Class II	1988-03-23
K874680	Laseguide 600A, 600B, 400A, and 400B	Laser Peripherals LLC	FCS	Class II	1988-03-23
K873937	Sdr 3500 (Philips Platinum +)	Philips North America LLC	IYO	Class II	1988-03-23
K872113	Omni-Vent, Series D	Stein-Gates Medical Equipment, Inc.	CBK	Class II	1988-03-23
K881057	Playtex Portable Non-Deod. & Deod Regular & Super	Playtex, Inc.	HIL	Class II	1988-03-22
K880740	Model Ta-Cs10 Spectraject Control Syringe	Spectramed, LLC	DQF	Class II	1988-03-22
K880573	Modified Nicolet Viking System	Nicolet Biomedical Instruments	IKN	Class II	1988-03-22
K880351	Vital System	Pace Tech, Inc.	DXN	Class II	1988-03-22
K880323	Medtronic Model 5411 Surgical Cable Adaptor	Medtronic, Inc.	DSA	Class II	1988-03-22
K880320	Electrode Cable	Vital Connections, Inc.	DSA	Class II	1988-03-22
K880180	Statflo	Imodex, Inc.	DWF	Class II	1988-03-22
K880158	Angioplasty Balloon Inflation Device	L.O.N. Research, Inc.	LIT	Class II	1988-03-22
K880103	Catheter, Cannula and Tubing, Vascular, Cardiopul.	Research Medical, Inc.	DWF	Class II	1988-03-22
K880071	Surgi-Light Nd:yag Laser for Urological Use	Laserguide	FCS	Class II	1988-03-22
K880066	Model 303D and 403D Adult Heart Rate & Respirator	Ivy Biomedical Systems, Inc.	DRT	Class II	1988-03-22
K875353	Percutaneous Arterial/venous Cannula Placement Kit	Dlp, Inc.	DWF	Class II	1988-03-22
K875057	Fukuda Model Ds-503 Dynascope Patient Monitor	Fukuda Denshi USA, Inc.	DPS	Class II	1988-03-22
K874492	Lawrence L4000 Reflectance Pulse Oximeter	Lawrence Medical Systems, Inc.	DQA	Class II	1988-03-22
K874306	Infectious Disease Protection Kit, Disposable	Busse Hospital Disposables	LGM	Class II	1988-03-22
K874233	Blood Pressure Sleeve W/tubing	Devcom, Inc.	DXQ	Class II	1988-03-22
K874198	Vitalog Hms-3000	Vitalog Corp.	DQA	Class II	1988-03-22
K873403	Cordis Steerable Guidewire	Cordis US Corp.	DQX	Class II	1988-03-22
K872126	Model 438-02 Cardifix Side Hook Implant. Pace Lead	Intermedics, Inc.	DTB	Class III	1988-03-22
K881128	Titanium Femoral Hip	Depuy, Inc.	JDI	Class II	1988-03-21
K881051	Safety Plus Model 501	Safety Rehab Systems, Inc.	IOR	Class I	1988-03-21
K881048	Airstrip* Waterproof First Aid Dress/post-Opera.	Smith & Nephew, Inc.	FRO	Unclassified	1988-03-21
K881000	Keratinocyte Growth Medium (Kgm)	Clonetics Corp.	KIT	Class I	1988-03-21
K880998	Sternum Spreader, Pediatric	T. Korossurgical Instruments Corp.	GAD	Class I	1988-03-21