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 2715 of 3530

510(k) clearances, page 2715 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880437	Vision(r) Total Bilirubin with a Neonatal Claim	Abbott Medical	CIG	Class II	1988-08-03
K880155	Miller/galante Precoat Unicompartmental Knee	Zimmer GmbH	HSX	Class II	1988-08-03
K875311	Wellcozyme Hsv Wzo2	Wellcome Diagnostics	GQN	Class II	1988-08-03
K874417	Tash Pilot System	Everest & Jennings, Inc.	ITI	Class II	1988-08-03
K883119	Vpi Non-Adhesive Condom Catheter	Cook Incorporated	EYT	Class I	1988-08-02
K883057	Comfort Cath Male External Catheter	Sierra Laboratories, Inc.	EYT	Class I	1988-08-02
K883034	Wheelchair Bcw 6000	O'Tec Corp.	IOR	Class I	1988-08-02
K882834	Tissue Punch	Tri-Stage, Inc.	EKJ	Class I	1988-08-02
K882589	Emit Hva Amphetamine Assay	Syva Co.	DKZ	Class II	1988-08-02
K882497	Enzymatic CO2 Reagent Set	American Monitor Corp.	KHS	Class II	1988-08-02
K882459	Diazo, Colorimetric Bilirubin	Tech-Neal Scientific, Inc.	CIG	Class II	1988-08-02
K882372	Resubmitted Diode Laser Coagulator	CooperVision, Inc.	HQF	Class II	1988-08-02
K882366	Rhythmscan Hr Holter Recorder	Brentwood Instruments, Inc.	DSH	Class II	1988-08-02
K882364	Kotex Lightdays Longs Deodorant & Reg. Pantiliners	Kimberly-Clark Corporation	HHD	Class I	1988-08-02
K882337	Model #825 Adult Stim. Pads Polymer Type	Cardiotronics, Inc.	LDD	Class II	1988-08-02
K882319	Telemetric Stethoscope	Vital Signs, Inc.	BZT	Class II	1988-08-02
K882307	D-Chem	Photec Diagnostics, Inc.	JJE	Class I	1988-08-02
K882220	Calibration Kit	King Diagnostics, Inc.	JIW	Class II	1988-08-02
K882209	Mediblend (Tm) Clinical Blood Gas Mixtures	Linde Div. Union Carbide Corp.	CHL	Class II	1988-08-02
K882157	Panamex(tm) Ureteral Stent	Kingston Technologies, Inc.	FAD	Class II	1988-08-02
K882118	Model 700 Patient Monitor	Ivy Biomedical Systems, Inc.	DRS	Class II	1988-08-02
K882095	Modification of Behring Rapimat Ii/t	Behring Diagnostics, Inc.	JJQ	Class I	1988-08-02
K881981	Assist(tm) Aseptic Syringe Irrigation System	Ryder Intl. Corp.	KOD	Class II	1988-08-02
K881941	Emit Hva Opiate Assay	Syva Co.	DJG	Class II	1988-08-02
K881905	Model Micro Si Ambulatory ECG Monitor	Advanced Medical Products, Inc.	DSI	Class II	1988-08-02
K881806	Qlt Absolute Urine-Hcg Pregnancy Test	Quadra Logic Technologies, Inc.	JHI	Class II	1988-08-02
K881781	Catheter Strap	Baxter Healthcare Corporation	KOD	Class II	1988-08-02
K881475	System5rh Stationary Exercise Bicycle	Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.	DPS	Class II	1988-08-02
K881405	Siemens Intravaginal Transducer	Siemens Medical Solutions USA, Inc.	HGL	Class II	1988-08-02
K880575	Cardiolife Tec-7300 W/optional Accessories	Nihon Kohden America Inc	LDD	Class II	1988-08-02
K880357	Omnigraph 6000	Telemed Div.	DPS	Class II	1988-08-02
K882863	Minimum Essential Medium Eagle (Mem) No. 210-3512	J R Scientific	KIT	Class I	1988-08-01
K882861	Minimum Essential Medium Eagle No. 210-3514	J R Scientific	KIT	Class I	1988-08-01
K882860	Minimum Essential Medium Eagle No. 210-3510	J R Scientific	KIT	Class I	1988-08-01
K882854	Medium 199, Catalog No. 210-3536	J R Scientific	KIT	Class I	1988-08-01
K882853	Rpmi-1640 Medium, Catalog No. 210-3520	J R Scientific	KIT	Class I	1988-08-01
K882851	Rpmi-1640 Medium, Catalog No. 210-3523	J R Scientific	KIT	Class I	1988-08-01
K882850	Nutrient Mixture F-10 (Ham) No. 210-3550	J R Scientific	KIT	Class I	1988-08-01
K882849	Dulbecco's Modified Eagle's Medium No. 210-3500	J R Scientific	KIT	Class I	1988-08-01
K882848	Rpmi-1640 Medium, Catalog No. 210-3521	J R Scientific	KIT	Class I	1988-08-01
K882847	Minimum Essential Medium Eagle No. 210-3515	J R Scientific	KIT	Class I	1988-08-01
K882846	Dulbecco's Modified Eagle's Medium No. 210-3501	J R Scientific	KIT	Class I	1988-08-01
K882837	Dulbecco's Modified Eagle's Medium, No. 200-2183	J R Scientific	KIT	Class I	1988-08-01
K882831	Ace Cancellous Bone Screw	Buckman Co., Inc.	HWC	Class II	1988-08-01
K882500	Vaporizer, Anesthesia, Non-Heated	Anesthetic Vaporizer Services	CAD	Class II	1988-08-01
K882396	Aerosol Delivery Hood	Viratek, Inc.	BYL	Class I	1988-08-01
K882222	Determin Hemoglobin Alc/hi Perf Liq Chromatography	Bio-Rad	LCP	Class II	1988-08-01
K882051	Bio-Rad Hemoglobin Detector	Bio-Rad	LCP	Class II	1988-08-01
K881932	Ortho* Cytomegalovirus Identification Reagent	Ortho Diagnostic Systems, Inc.	GQH	Class II	1988-08-01
K881131	The Laitinen Stereotactic System	Sandstrom Trade & Technology, Inc.	HAW	Class II	1988-08-01