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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3037 of 3529

510(k) clearances, page 3037 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843109	Roche Reagent for Ast	Roche Diagnostic Systems, Inc.	CIT	Class II	1984-11-05
K842691	Hts Filter Digital Subtract. Angiography	Health Technology Services			1984-11-05
K842511	Band-Aid Brand Adhesive Bandage-Medica	Johnson & Johnson Professionals, Inc.	KGX	Class I	1984-11-05
K842410	Amer. Edwards Lab Flexiscope	American Edwards Laboratories	HRK	Class I	1984-11-05
K842301	Disposable Latex Bandage	Inmed Corp.	KGX	Class I	1984-11-05
K843894	Hdl Precipatating Reagent Set	Livonia Diagnostics, Inc.	LBR	Class I	1984-11-02
K843784	Vitajet Jet Insulin Injection Device	Vitajet Industriae Comercioltda.	KZE	Class II	1984-11-02
K843540	Abbott Htsh Eia Diagnostic Kit	Abbott Medical	JLW	Class II	1984-11-02
K842479	i.v. Teamate	Medical Delivery Systems	FRN	Class II	1984-11-02
K841913	Temptrend Peds Axillary Temp. Indicator	Biosynergy, Inc.	KPD	Class II	1984-11-02
K843962	Cbc-Plt-4 Whole Blood Control/multiple	R & D Systems, Inc.	JPK	Class II	1984-11-01
K843921	In the Canal Hearing Aid Rc, Redicanal	Omni Hearing Systems	ESD	Class I	1984-11-01
K843904	DNA Stat Test Kit	Whittaker Bioproducts, Inc.	LJM	Class II	1984-11-01
K843852	Apta-Bronchoscreen	Erich Jaeger, Inc.	BZC	Class II	1984-11-01
K843848	Aw Test	Erich Jaeger, Inc.	BZC	Class II	1984-11-01
K843424	Microprocessor 7200A Ventilator	Medtronic, Inc.	CBK	Class II	1984-11-01
K843225	Colorzyme Ndna Test System	IMMUNO CONCEPTS, NA, Ltd.	DHN	Class II	1984-11-01
K843011	Term Guard 5000 Uterine Activity	Tokos Medical Corp.	HFM	Class II	1984-11-01
K842772	Pharmacia B2-Micro Ria	Pharmacia, Inc.	JGZ	Class II	1984-11-01
K842048	Sun-One	Ensun Medical Products, Inc.	BZQ	Class II	1984-11-01
K841984	Autoflour III System	Tech America Diagnostics	DHN	Class II	1984-11-01
K833763	Pericardial Patch	American Edwards Laboratories	DXZ	Class II	1984-11-01
K844019	Strep Id Triplate	Remel Inc	JTO	Class I	1984-10-31
K844014	Ono/co-Two (Tm) Systems	Micro-Bio-Logics	JTY	Class II	1984-10-31
K843997	Ao-10 Automated Osmometer	bioMerieux, Inc.	JJM	Class I	1984-10-31
K843982	O.b. Basin Set	Pro-Lab, Inc.	FRG	Class II	1984-10-31
K843872	Ethanol Controls Low & High E5133/e5258	Sigma Chemical Co.	DKC	Class I	1984-10-31
K843816	Tal-Clip	Talboy, Inc.	GDJ	Class I	1984-10-31
K843774	Raichem X-Hbdh Reagent	Reagents Applications, Inc.	JMK	Class I	1984-10-31
K843704	Mcghan Tissue Expander	Mcghan Medical Corp.	LCJ	Unclassified	1984-10-31
K843693	Jacobs High Vacuum Suction Unit 05-2570	J. Sklar Mfg. Co., Inc.	BTA	Class II	1984-10-31
K843692	Flu Ven i.v. Set 0153-C Perma-Set	Venusa Ltd.	FPA	Class II	1984-10-31
K843684	Sigma Sudan Black Reagent 380-1	Sigma Chemical Co.	HZZ	Class I	1984-10-31
K843616	Avi Guardian 400 Infusion Pump	Avi, Inc.	FRN	Class II	1984-10-31
K843615	Avi Guardian Micro 410 Infusion Pump	Avi, Inc.	FRN	Class II	1984-10-31
K843613	Fluorescent Treponemel Antibody-Absorb	Immuno-Products Industries	GMS	Class II	1984-10-31
K843603	Auto Suture Poly Gia Surgical Stapler	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1984-10-31
K843579	Ultraclone Ecl-01-1100	Earl-Clay Laboratories, Inc.	KIR	Class I	1984-10-31
K843578	Ultraclone Ecl-01-2100 Cell Line	Earl-Clay Laboratories, Inc.	KIR	Class I	1984-10-31
K843577	Ultraxlone Ecl-01-1000 Cell Line	Earl-Clay Laboratories, Inc.	KIR	Class I	1984-10-31
K843564	Msi Surgi-Grade Suture Tray	Medical Sterilization, Inc.	FSM	Class I	1984-10-31
K843548	Intermedics Syringe Pump 710-02	Intermedics, Inc.	FRN	Class II	1984-10-31
K843499	Arthroscopy Leg Holder	Eder Instrument Co, Inc.			1984-10-31
K843497	Surgical Knives & Probes	Eder Instrument Co, Inc.	EMF	Class I	1984-10-31
K843496	Drape Surgical Utility Drape Sterile	Busse Hospital Disposables	KKX	Class II	1984-10-31
K843475	Pharma-Plast Single Use Overshoes	Zimmar Consulting, Ltd.	FXP	Class I	1984-10-31
K843473	Pharma-Plast Insulin Syringe	Zimmar Consulting, Ltd.	FMF	Class II	1984-10-31
K843472	Pharma-Plast Syringe with Needle	Zimmar Consulting, Ltd.	FMF	Class II	1984-10-31
K843471	Pharma-Plast Syringe	Zimmar Consulting, Ltd.	FMF	Class II	1984-10-31
K843360	Artap Arterial Blood Sampling Device	Analytical Products, Inc.	CBT	Class I	1984-10-31