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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2528 of 3531

510(k) clearances, page 2528 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903240	Thompson Type His Prosthesis	Onyx Medical LLC	KWL	Class II	1990-07-30
K902797	Opus Tm T-Uptake Test System	Pb Diagnostic Systems, Inc.	KHQ	Class II	1990-07-30
K902762	Pm14 Soft Air Compressor	Precision Medical, Inc.	BTI	Class II	1990-07-30
K902312	Cospan Pediatric Continuous Spinal Anesthesia Tray	Kendall Healthcare Products Co. Div.Of Tyco Health	CAZ	Class II	1990-07-30
K901958	Guardian Safe Bow	Lancer Orthodontics, Inc.	DZB	Class II	1990-07-30
K901957	Mustang, C.a.t.	Lancer Orthodontics, Inc.	EJF	Class I	1990-07-30
K896787	Transcutaneous Electrical Nerve Stimulation	Saratoga Intl., Inc.	GZJ	Class II	1990-07-30
K903213	Arthroscopic Surgical Knives Models 1001 and 1002	Percutaneous Technologies	HEX	Class II	1990-07-27
K903023	Heritage III (Htc) Itc Type Hearing Aid	Hearing Tech, Inc.	ESD	Class I	1990-07-27
K903016	Synermed Triglycerides Reagent Kit	Synermed, Inc.	CDT	Class I	1990-07-27
K902922	Microzyme T4 Enzyme Immunoassay Kit	IMMUNOTECH s.r.o.	CDX	Class II	1990-07-27
K902877	Total Iron for Manual/automated	Catachem, Inc.	JIY	Class I	1990-07-27
K902760	Amersham Tsh Control Sera	Amersham Corp.	JJX	Class I	1990-07-27
K902709	Secutainer	Preserve	JKA	Class II	1990-07-27
K902669	Bpa, Body Position Alarm	Bagrad	LZW	Unclassified	1990-07-27
K902633	Cut Resistant Glove Liner	Zimmer GmbH	LYU	Class I	1990-07-27
K902581	Emit(r) II Calibrator Level 0 (Negative)	Syva Co.	DKB	Class II	1990-07-27
K902579	Emit(r) II Cocaine Metabolite Assay	Syva Co.	DIO	Class II	1990-07-27
K902577	Emit(r) II Opiate Assay	Syva Co.	DJG	Class II	1990-07-27
K902500	Ar-1600G Auto-Refractometer	Nidek, Inc.	HKO	Class I	1990-07-27
K902481	Gambro Alwall Gfs Plus 11, 16 & 20 Hollow Fiber	Gambro, Inc.	FJI	Class II	1990-07-27
K902360	Hema-Screen	Immunostics, Inc.	KHE	Class II	1990-07-27
K902265	Flexible Snare	Annex Medical, Inc.	FDI	Class II	1990-07-27
K902254	Escort Model 400T Telemetry ECG Monitor	Medical Data Electronics	DXH	Class II	1990-07-27
K902121	Lake Gastrostomy Tube	Lake Medical Products, Inc.	KGC	Class II	1990-07-27
K902115	Palapress(r) Vario Resin	Kulzer GmbH	EBI	Class II	1990-07-27
K902101	Peritoneal Catheters	Akcess Medical Products, Inc.	FJS	Class II	1990-07-27
K902097	Model Tr Rectal Suction Biopsy Tube	Medical Measurements, Inc.	FCK	Class II	1990-07-27
K902077	T19s Biopsy Needle	Ohio Medical Instrument Co., Inc.	KNW	Class II	1990-07-27
K902039	Rarex & Optex X-Ray Screens	Mci Optonix	EAM	Class I	1990-07-27
K901950	Diter Ultrasonic S 3000	Diter Elektroniikka Oy	IMI	Class II	1990-07-27
K901882	Uresil Endoscopic Laser Overtube	Uresil, LLC	KOQ	Class I	1990-07-27
K901861	Biochem 9100 Multigas Monitor	Biochem International, Inc.	CCK	Class II	1990-07-27
K901660	Quidel Chlamydia Test	Ortho-Clinical Diagnostics, Inc.	LJC	Class I	1990-07-27
K901478	Delmed 80/2 Dialysis System W/last Bag Option	Delmed, Inc.	FKX	Class II	1990-07-27
K901477	Delmed 80/2 Dialysis System W/ultrafiltration	Delmed, Inc.	FKX	Class II	1990-07-27
K901473	Gc-01 Through Gc-99 Acetate Concentrate	Granite Chemical Co., Inc.	KPO	Class II	1990-07-27
K901472	Gc-Bc-01, Gc-Bc-02, Gc-Bc-03 Bicarbonate Dry Packs	Granite Chemical Co., Inc.	KPO	Class II	1990-07-27
K901471	Gc-1000 Through Gc-3005 Acid Concentrate	Granite Chemical Co., Inc.	KPO	Class II	1990-07-27
K901409	Transducer Protector	Filtertek, Inc.	FIB	Class II	1990-07-27
K901341	Rexton Rx12 Power Plus W/dual Receiver	Rexton, Inc.	ESD	Class I	1990-07-27
K900877	Opthalmic Quality Sunglasses, Non-Prescription	Sunglass Originals, Inc.	HQY	Class I	1990-07-27
K900793	Interpore Imz Single Tooth Attachment System	Interpore Intl.	DZE	Class II	1990-07-27
K900474	Imx Cmv Igg Antibody Assay	Abbott Medical	LFZ	Class II	1990-07-27
K900473	Imx Cmv Igm Antibody Assay	Abbott Medical	LFZ	Class II	1990-07-27
K900432	Model #M8 Electronic Sterilizer	Midmark Corp	FLE	Class II	1990-07-27
K900058	Wilson-Cook Biliary Motility Catheter	Wilson-Cook Medical Inc.	FFX	Class II	1990-07-27
K900018	Hollow Fiber Dialyzer, Bio Care Ps 130	National Medical Care, Medical Products Div., Inc.	KDI	Class II	1990-07-27
K895000	Nemectron Microwave	Nemectron Medical, Inc.	IOA	Class II	1990-07-27
K902971	Zenith Hylo and Verti-Lift Chiropractic Tables	Williams Manufacturing Co.	INQ	Class I	1990-07-26