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 3234 of 3528

510(k) clearances, page 3234 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820846	Antimicrobial Suscep. Test, Mueller	Blue Ridge Media Co.	JTZ	Class II	1982-04-16
K820845	Dulture Media, Selective & Non-Differ	Blue Ridge Media Co.	JSJ	Class I	1982-04-16
K820844	Culture Media, Selective & Differential	Blue Ridge Media Co.	JSI	Class I	1982-04-16
K820843	Culture Media Selective Broth	Blue Ridge Media Co.	JSD	Class I	1982-04-16
K820842	Culture Media, Non-Selective/differ	Blue Ridge Media Co.	JSE	Class I	1982-04-16
K820841	Culture Media, Multiple Biochemical	Blue Ridge Media Co.	JSE	Class I	1982-04-16
K820840	Culture Media, General Nutrient Broth	Blue Ridge Media Co.	JSC	Class I	1982-04-16
K820839	Culture Media, Single Biochem. Test	Blue Ridge Media Co.	JSF	Class I	1982-04-16
K820769	Gambro Lundia 10 3N Parallel Flow Dial	Gambro, Inc.	FKQ	Class II	1982-04-16
K820760	Lh Radioimmunoassay Test System	Monobind, Inc.	CEP	Class I	1982-04-16
K820746	Newport Ventilator Model E100	Newport Medical Instruments, Inc.	CBK	Class II	1982-04-16
K820499	Fitc Anti-Rabies Monoclonal Globulin	Centocor, Inc.	GOI	Class II	1982-04-16
K820487	Implantible Suture Sleeve	Intermedics, Inc.	DTB	Class III	1982-04-16
K820452	Phonotrace 2000	Lowrance Electronics, Inc.	DXH	Class II	1982-04-16
K820370	Nasal Oxygen Catheter	American Pharmaseal Div. Ahsc	BZB	Class I	1982-04-16
K820369	Suction Catheters & Kits	American Pharmaseal Div. Ahsc	BSY	Class I	1982-04-16
K820248	Rodder Volume Ventilator	Pharmaquest Corp.	CBK	Class II	1982-04-16
K827209	System 287 Scanner	Diagnostic Sonar USA			1982-04-15
K820911	Pbc Needle by Nipro Med. Industries	Philadelphia Biologics Center	FMI	Class II	1982-04-15
K820901	Cold Roll	North Bank Labs, Inc.	IME	Class I	1982-04-15
K820885	Marquette Option II ECG Analysis Comput	Marquette Electronics, Inc.	LOS		1982-04-15
K820864	Norton Manifold	Norton Performance Plastics Corp.	DTL	Class II	1982-04-15
K820852	Mecron Concavex Flexible Intramedullary	Serrano Intl.	HSB	Class II	1982-04-15
K820836	Mark III Oxygen Walker System	Union Carbide Corp.	BYJ	Class II	1982-04-15
K820832	Phosphorus Il	American Monitor Corp.	CED	Class I	1982-04-15
K820825	Cardiac Monitor - Rate Alarm	Hewlett-Packard Co.	DRT	Class II	1982-04-15
K820783	Castle Microcomputer Sterilizer Control	Sybron Corp.	FLF	Class II	1982-04-15
K820776	Cannuoated Trochar	The Anspach Effort, Inc.	HRX	Class II	1982-04-15
K820765	Pleural Drainage Reservoir	Innovative Surgical Products, Inc.	GCX	Class II	1982-04-15
K820764	Ivac Model 160 Air-in-Line Sensor	Y	FRN	Class II	1982-04-15
K820763	Enzym-Linked T3	Icl Scientific	CDP	Class II	1982-04-15
K820754	Amerlex Esh Kit	Amersham Corp.	CGJ	Class I	1982-04-15
K820747	Monoject Saf-T-Lock	Sherwood Medical Co.	FPA	Class II	1982-04-15
K820744	Il Model 1301, Ph Blood Gas System	Instrumentation Laboratory Co.	CHL	Class II	1982-04-15
K820742	Nihon Kohden Blood Flowmeters #Mfv-1100	Nihon Kohden America Inc	DPW	Class II	1982-04-15
K820736	Central Venous Access Catheter	Hemed, Inc.	DQY	Class II	1982-04-15
K820681	Castle(r) 2510 & 2610 Minor Surg. Light	Sybron Corp.	FSY	Class II	1982-04-15
K820657	Pulse Generator 678 B	Siemens Elema AB	DXY	Class III	1982-04-15
K820645	Infant Monitor	Healthdyne, Inc.	BZQ	Class II	1982-04-15
K820599	Autospirometer Hi-498	Medical Equipment Designs, Inc.	BZG	Class II	1982-04-15
K820516	Arterial Canalization Device	Alimed, LLC	DQY	Class II	1982-04-15
K820477	Algorithm of the Arrhythmia Mon. Sys	Hewlett-Packard Co.	DSI	Class II	1982-04-15
K820384	Glass Syringes, Drug, Luer Lock	Procedure Products, Inc.	FMF	Class II	1982-04-15
K813223	Disposable Plastic Syringe W/needle	Sam Joo Industrial Co., Ltd.	DXG	Class II	1982-04-15
K820893	Disposable Surgical Face Mask	Anago, Inc.	FXX	Class II	1982-04-14
K820872	Curity Shethoscope Securing Pads	The Kendal Co.	KGX	Class I	1982-04-14
K820834	Percor Percutaneous Introducer	Datascope Corp.	DYB	Class II	1982-04-14
K820828	Samm	Dart Medical Equipment	DXH	Class II	1982-04-14
K820821	Mic-2000 Plus, 96 Channel Dispenser	Dynatech Corp.	JTC	Class I	1982-04-14
K820768	Colorimetric Ldh Reagent Set	Biorent Diagnostic, Inc.	CFH	Class II	1982-04-14