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 2687 of 3530

510(k) clearances, page 2687 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884439	Gastrostomy Feeding Device	Southside Biotechnology	KNT	Class II	1988-12-05
K884326	Filtral Tm 8 Hemodialyzer	Hospal Medical Corp.	KDI	Class II	1988-12-05
K884244	Intersept* Prebypass Filter	Medtronic Blood Systems, Inc.	KRJ	Class II	1988-12-05
K884200	Usci Tandem Adapter	C.R. Bard Inc	DTL	Class II	1988-12-05
K884006	Hemat 12	Texas Intl. Laboratories, Inc.	GKZ	Class II	1988-12-05
K884005	Endocardial Pacing Leads-Anchoring Sleeve Modified	Medtronic, Inc.	DTB	Class III	1988-12-05
K884004	Rubeola Test	Gull Laboratories, Inc.	GRE	Class I	1988-12-05
K883997	Sysmex Ne-8000	Toa Medical Electronics USA, Inc.	GKZ	Class II	1988-12-05
K883980	Landmark Venous Access Drive (Additional Sizes)	Menlo Care, Inc.	FOZ	Class II	1988-12-05
K883947	ISO-100 Isolation Amplifier	Telediagnostic Systems, Inc.	GYE	Class II	1988-12-05
K883884	Prostatic Core-Cut Needle	Euro-Med Intl.	KNW	Class II	1988-12-05
K883761	Ionodent II (6 Volts)	U.S. Apatite Corp.	EFW	Class I	1988-12-05
K883723	Flexible Myocardial Biopsy Forceps	Cook Inc.	DWZ	Class II	1988-12-05
K883319	Hill Nasogastric Tube	Zinetics Medical, Inc.	KNT	Class II	1988-12-05
K883148	Immuknow-Check Hcg Assay Kit, Cat. #900-40	Diagnostic Chemicals, Ltd. (USA)	DHA	Class II	1988-12-05
K883071	Sarns Mp4 Cardioplegia Delivery System	3M Health Care, Sarns	DTR	Class II	1988-12-05
K883070	Encor Unipolar Vs-1 Leads	Cordis Leads, Inc.	DTB	Class III	1988-12-05
K882918	Kim Naso-Intestinal Tube	Sheridan Catheter Corp.	KNT	Class II	1988-12-05
K882835	Indirect Fluorescent Assay for (Hcmv)	Stellar Bio Systems, Inc.	GQH	Class II	1988-12-05
K882414	Blood Reservoir, Cardiopulmonary Bypass	Gish Biomedical, Inc.	DTN	Class II	1988-12-05
K881813	Chronodynamics Data Recorder (Cdr)-100	Chronodynamics, Inc.	FLL	Class II	1988-12-05
K881206	Chronamed Cm101	Chronamed Corp.	CCK	Class II	1988-12-05
K880303	Polycord II	Technetics, Inc.	DSH	Class II	1988-12-05
K875134	Omron Ultrasonic Nebulizer Ne-U06	Nidek, Inc.	CAF	Class II	1988-12-05
K874326	System VI Monitor	Air-Shields, Inc.	DPS	Class II	1988-12-05
K884566	Vision Lyte (Tm) Potassium	Abbott Medical	CEM	Class II	1988-12-02
K884436	Modified Low-Temp. Freezer Model Hlt-80Ls-85	Harris Mfg. Co.	KSE	Class II	1988-12-02
K884431	Hexascan Handpiece for Argon/dye Laser	California Laboratories, Inc.	GEX	Class II	1988-12-02
K884429	Always Scented or Scented Deodorized Menstrual Pad	Procter & Gamble Co.	HHL	Class II	1988-12-02
K884428	Always Unscented Menstrual Pads	Procter & Gamble Co.	HHD	Class I	1988-12-02
K884413	Cusa System 200H Ultrasonic Surgical Aspirator	Medtronic, Inc.	LBK	Unclassified	1988-12-02
K884412	Cusa System 200C,t & M Ultrasonic Surgical Aspira.	Medtronic, Inc.	LBK	Unclassified	1988-12-02
K884207	Resubmitted Abbott Testpack(tm) Hcg Combo	Abbott Medical	DHA	Class II	1988-12-02
K884143	Nova Stat Profile 7 Analyzer Quality Control Mater	Nova Biomedical Corporation	CHL	Class II	1988-12-02
K884125	Bio-Tek Automated Microplate Washer Model El403	Bio-Tek Instruments, Inc.	JTC	Class I	1988-12-02
K884085	Tandem Icon QSR Ckmb Immunoenzymetric Assay	Hybritech, Inc.	JHY	Class II	1988-12-02
K884081	Interim, Temporary Cement	Scientific Pharmaceuticals, Inc.	EMA	Class II	1988-12-02
K884054	Modification of the Cedia Digoxin Assay	Microgenics Corporation	KXT	Class II	1988-12-02
K883933	Introducing Catheter	Devices for Vascular Intervention, Inc.	DYB	Class II	1988-12-02
K883810	Delfia Triiodothyronine (T3) Kit	Pharmacia, Inc.	CDP	Class II	1988-12-02
K882431	Confidence(tm) Sterile, Disp., Latex Surg. Gloves	Charise Charles, Ltd.	KGO	Class I	1988-12-02
K881784	Klein Needle	E.L. Medico Intl., Inc.	GDM	Class I	1988-12-02
K881783	Klein Handle	E.L. Medico Intl., Inc.	GDM	Class I	1988-12-02
K884623	Safe-Tec Capillary Blood Collection Tube	Safe-Tec Clinical Products, Inc.	GIO	Class I	1988-12-01
K884610	Interlocking Intramedullary Nails	Depuy, Inc.	HSB	Class II	1988-12-01
K883968	Tenderfoot	Accriva Diagnostics, Inc.	FMK	Class II	1988-12-01
K883769	Excel Inflate-Aid	Medical Profiles, Inc.	DXT	Class II	1988-12-01
K883752	Acuson L538 Transducer	Acuson Corp.	IYO	Class II	1988-12-01
K883122	Amk Total Knee System without Porocoat	Depuy, Inc.	JWH	Class II	1988-12-01
K882469	Cordex Shaver, Blades, Recharger and Batteries	Orthoconcept, Inc.	HRX	Class II	1988-12-01