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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3098 of 3528

510(k) clearances, page 3098 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K834368	Surgical Disposable Sterile & Nonsteril	Marbex, Inc.	FMF	Class II	1984-03-05
K834361	Jsb Jet Syringe	C.B.S. Biotechnics, Inc.	EGM	Class II	1984-03-05
K834359	Absorbent Incontinent Pads & Briefs	Weyerhaeuser Co.	EYQ	Class I	1984-03-05
K834339	Boundary Reinforced Single-Use Gowns	Procter & Gamble Mfg. Co.			1984-03-05
K834210	Stratus Total Thyroxine Fluorometric	American Dade	KLI	Class II	1984-03-05
K834201	Tct-1 Treatment Couch	Therados, Inc.	JAI	Class II	1984-03-05
K834187	Jakobi Surg. Instruments #6 50	Imm Enterprises, Ltd.	HKY	Class II	1984-03-05
K833982	Model IV 100B-Da Infant Ventilator	Sechrist Industries Inc	CBK	Class II	1984-03-05
K833783	Dispos. I/a & Irrigation Handpieces	CooperVision, Inc.	HQC	Class II	1984-03-05
K833642	Phako Systems via 2000	Pharosystems, Inc.	HQC	Class II	1984-03-05
K833539	Dowing Ophthalmic Chair Ac-Powered	Vision Health Technology	HME	Class I	1984-03-05
K833538	Dowing Ophthalmic Chair-Non/ac Power	Vision Health Technology	HMD	Class I	1984-03-05
K833251	Model Mk II TENS	European Electronic Systems, Ltd.	GZJ	Class II	1984-03-05
K832441	Suture-Aid Booties	Omega-Med Intl., Inc.	KDC	Class I	1984-03-05
K840584	Spottest Acridine Orange Stain	Difco Laboratories, Inc.	JTO	Class I	1984-03-02
K840534	Liquid Oxygen System	The John Bunn Co.	BYJ	Class II	1984-03-02
K840518	Sabouraud Agar Slants	Scientific Device Laboratory, Inc.	JSG	Class I	1984-03-02
K840483	Novobiocin Disc	Remel Co.	JTO	Class I	1984-03-02
K840453	Medishield Pvm Respirometer	Ohio Medical Products	BZK	Class II	1984-03-02
K840279	Drager Baromed	Draeger, Inc.	CAP	Class II	1984-03-02
K840211	Fibri-Prest Automate Ha34	Wellcome Diagnostics	KQJ	Class II	1984-03-02
K840201	Epidural Catheter Tray	Aries Medical, Inc.	MJL	Class II	1984-03-02
K840170	Cell-Dyn 100 Whole Blood Platelet	Abbott Diagnostics	GKL	Class II	1984-03-02
K840160	B-Strep-Tect-II	Uti-Tect, Inc.	JSI	Class I	1984-03-02
K840048	Phadebact Csf Positive Controls	Pharmacia, Inc.	GTY	Class I	1984-03-02
K840031	Microbial Differentiation	Anaerobe Systems	JTO	Class I	1984-03-02
K840030	Reagents	Anaerobe Systems	JTO	Class I	1984-03-02
K840029	Strips	Anaerobe Systems	JTO	Class I	1984-03-02
K840028	Discs	Anaerobe Systems	JTO	Class I	1984-03-02
K834518	Liquid Stable Triglycerides Reagent Set	Medical Analysis Systems, Inc.	CDT	Class I	1984-03-02
K834428	Aldosterone Radioimmunoassay Test Kit	Serono Laboratories, Inc.	CJM	Class II	1984-03-02
K834328	Dat Test for Chagas' Disease	Sero-Immuno Diagnostics, Inc.	GNE	Class I	1984-03-02
K834242	Adp Ifa Test for Chlamydiae Trachomatis	Apple Diagnostic Products	LJP	Class I	1984-03-02
K834021	Sysmex Cc-780 Eight Parameter Aut0	Toa Medical Electronics USA, Inc.			1984-03-02
K833838	Silverak	Anil S. Gautam	LCN	Class I	1984-03-02
K833694	Texas Bio Scan	Texas Bio Scan	HKI	Class II	1984-03-02
K833687	Dispos. Enteric Feeding Tubes W/safe-T	Superior Plastic Products Corp.	KNT	Class II	1984-03-02
K833439	Porocoat Neb Total Hip System	Depuy, Inc.	LPH	Class II	1984-03-02
K833404	Bdh Bipolar Femoral Component A3	Carbomedics, Inc.	KWY	Class II	1984-03-02
K832919	Opti-Beam IV	Dentsply Intl.	EAZ	Class I	1984-03-02
K840003	Disposable Icp Kit Diff. Sizes	Cerenovus, Inc.	GWM	Class II	1984-02-28
K834392	Labial Cuspid Tube	Alexotek Co.	DZD	Class I	1984-02-28
K834073	Central Vein Catherization Tray Cc-20	Packaging Technologies, Inc.	FOZ	Class II	1984-02-28
K833686	Filtech Technetium-99Mm Radiopharmaceu	Summa Medical Corp.			1984-02-28
K833225	Calibre-Tentative Tradename	Advanced Technology Laboratories, Inc.	IYO	Class II	1984-02-28
K832847	Medi-Ject	Jack H. Ritterskamp	KZH	Class II	1984-02-28
K832470	Infusion Pump	Delta Medical Industries	FRN	Class II	1984-02-28
K840697	Calm Water Flotation Hospital Bed	Calm Handicap Supplies, Inc.	IOQ	Class II	1984-02-27
K840640	Positelec Wheelchair	Poirier S.A.	ITI	Class II	1984-02-27
K840637	Hospitalier Wheelchair	Poirier S.A.	IOR	Class I	1984-02-27