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 2580 of 3530

510(k) clearances, page 2580 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K895711	Acufex Interference Screw, Sterile	Acufex Microsurgical, Inc.	HWC	Class II	1990-01-09
K895162	Traumafuse Trach Shield	The Traumafuse Co.	BTO	Class II	1990-01-09
K895082	Voyager Px	Smith-Perry Corp.	BYJ	Class II	1990-01-09
K894568	New Rad-8 Treatment Planning Computer System	Advanced Medical Systems, Inc.	KPQ	Class II	1990-01-09
K894556	Spiroteq	System Analysis Corp.	BZG	Class II	1990-01-09
K897008	Menstrual Tampon	Personal Products Co.	HEB	Class II	1990-01-08
K896491	Inamed Closed-Wound Drain System	Inamed Development Co.	GCY	Class I	1990-01-08
K895908	Mules Sphere Glass (Several Sizes)	Ginsberg Scientific, Inc.	HPZ	Class II	1990-01-08
K894628	Model Ds-3300 Dynascope Patient Monitor	Fukuda Denshi USA, Inc.	DSI	Class II	1990-01-08
K896045	Whiteside Ortholoc Modular-C Total Knee System	Dow Corning Wright	JWH	Class II	1990-01-05
K892411	Mennen Bone Fixation Device	Dentsply Intl.	JDQ	Class II	1990-01-05
K881263	Model 500A Vascular Spectrum Analyzer W/doppler	Multigon Industries, Inc.	HGL	Class II	1990-01-05
K897120	Equip Covers, Sterile	Amedic USA	KKX	Class II	1990-01-04
K896615	Cine Camera Control Model Pk2037	Perkins Mfg. Co.	IZJ	Class II	1990-01-04
K896606	Jackson Fine Needle Aspiration System	National-Standard Medical Products	GAA	Class I	1990-01-04
K896605	Kopans Stabilized Needle Aspiration Guide (Snag)	National-Standard Medical Products	GAA	Class I	1990-01-04
K896452	Kinemax Tibial Stem Extension	Howmedica Corp.	JWH	Class II	1990-01-04
K896076	L(3), Lysnig Lead Latex Radiation Glove(r)	Advance Medical Designs Inc	LZC	Class I	1990-01-04
K896065	Wallach Cc/brush	CooperSurgical, Inc.	HHT	Class II	1990-01-04
K896023	Ohmeda 9000 Syringe Pump	GE Healthcare	FRN	Class II	1990-01-04
K895961	Model Mc6500 Electrocardiograph	Cambridge Medical Instruments, Inc.	DSH	Class II	1990-01-04
K895935	Icor Cmu Q Plus	Icor AB	BZL	Class II	1990-01-04
K895932	Psg(tm) Edm(tm) Infusion Catheter	Peripheral Systems Group	DQY	Class II	1990-01-04
K895903	Ivt 0.014 Guide Wire	Intensive Technology, Inc.	DQX	Class II	1990-01-04
K895720	Mobilimb J1 Tmj Cpm Unit	Toronto Medical Corp.	BXB	Class I	1990-01-04
K895590	Ite Hearing Aid Model Pa	Best Aid, Inc.	ESD	Class I	1990-01-04
K895587	Cross Medical Product Pedicle Awl	Cross Medical Products, Inc.	HWJ	Class I	1990-01-04
K895517	Aural-Tech Ite Hearing Aid Model at-1S, 1Sa, 1Sc	Aural Technologies, Inc.	ESD	Class I	1990-01-04
K895241	Intramedullary Hip Screw	Richards Medical Co., Inc.	KTT	Class II	1990-01-04
K894964	K-2 TENS or Med TENS	Oms Medical Supplies, Inc.	GZJ	Class II	1990-01-04
K894855	Model 5070; Dual Planar Pair	Medical Advances, Inc.	LNH	Class II	1990-01-04
K893233	Disposable Needle, Aspiration and Injection	Pioneer Intl. Co.	FMF	Class II	1990-01-04
K891987	Bio-Stym 250 (Muscle Stimulator)	Electronic Health Technologies, Inc.	IPF	Class II	1990-01-04
K891914	Itc Prescription Series Model Ca and C	Us Hearing Centers, Inc.	ESD	Class I	1990-01-04
K890192	Luque III Spinal System and Luque Mini-Set	Danek Medical, Inc.	KWP	Class II	1990-01-04
K896983	Sunbronze Sb24c/65 Ultra	Sunbronze	LEJ	Class II	1990-01-03
K896904	B.a.c. 3000 Chair/stander	Luconex, Inc.	IPL	Class II	1990-01-03
K896674	Amsco Quantum Light	American Sterilizer Co.	FSY	Class II	1990-01-03
K896311	Optex Blood Gas Monitoring System	Optex Biomedical	CCE	Class II	1990-01-03
K896192	Medisonic Pneu-Neb	Medisonic U.S.A., Inc.	CAF	Class II	1990-01-03
K896019	Modified Disp. Chiba-Type Needle Designated Aspi.	Dlp, Inc.	GAA	Class I	1990-01-03
K895874	Optilase Yag Model 1000	Trimedyne, Inc.	GEX	Class II	1990-01-03
K895774	Gyn-Probe	Trimedyne, Inc.	GEX	Class II	1990-01-03
K895417	Arrow Large-Bore Dual Lumen Hemodialysis Kit	Arrow Intl., Inc.	LFJ	Class II	1990-01-03
K894722	Renner-Plan	W.D. Renner Consulting Co.	IYE	Class II	1990-01-03
K894226	Silastic Soft Sheeting	Dow Corning Wright	FRO	Unclassified	1990-01-03
K893622	Preemicare Model 200-II Infant Transport Ventil.	Preemicare Corp.	CBK	Class II	1990-01-03
K890500	Elt or Ergonomic Lift Trainer	Physical Health Devices, Inc.	HCC	Class II	1990-01-03
K897060	Cbc-Cal(tm) Plus Hematology Calibrator/multiple	R & D Systems, Inc.	KSA	Class II	1990-01-02
K897025	Antinuclear Antibody (Ana) Test System	Zeus Scientific LLC	DHN	Class II	1990-01-02