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 2026-11-05, 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 2290 of 3531

510(k) clearances, page 2290 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925020	Tracheostomy Care Kit (Sterile)	Customed, Inc	JOH	Class II	1993-07-07
K924212	Stryker Endoscopy Cholangiogram Kit	Stryker Corp.	GBZ	Class I	1993-07-07
K921851	4 Sure Tm Suction Catheters & Kits	Boston Pacific Medical, Inc.	BSY	Class I	1993-07-07
K921751	Infuse-a-Cath Silicone Central Venous Catheter	Strato Medical Corp.	LJS	Class II	1993-07-07
K915273	Lifeport Attachable System W/inducer Kit Lps 5555	Strato Medical Corp.	LJT	Class II	1993-07-07
K932225	Anti-Cardiolipin Antibody Screening Test System	IMMUNO CONCEPTS, NA, Ltd.	MID	Class II	1993-07-06
K931901	Lactocard	Touch Scientific, Inc.	DEG	Class I	1993-07-06
K931465	Rep Alkaline Hb-15 #3196,-8 #3197,-4 3198	Helena Laboratories, Corp.	JBD	Class II	1993-07-06
K930889	Roche Cardiotrol-Ck	Roche Diagnostic Systems, Inc.	JJT	Class I	1993-07-06
K930449	Marco, Marcotilt, Encore and Custom Chair	Marco Ophthalmic, Inc.	HME	Class I	1993-07-06
K930447	Marco H and Ts-1 Instrument Tables	Marco Ophthalmic, Inc.	HRJ	Class I	1993-07-06
K930446	Marco Trial Sets	Marco Ophthalmic, Inc.	HPC	Class I	1993-07-06
K930443	Marco Cp-600 Auto Chart Projector/cp-1 Chart Proje	Marco Ophthalmic, Inc.	HOS	Class I	1993-07-06
K930441	Marco Standard Lensmeters 101,201	Marco Ophthalmic, Inc.	HLM	Class I	1993-07-06
K930440	Marco International Stand	Marco Ophthalmic, Inc.	HMF	Class I	1993-07-06
K930161	Anago Spinal Anesthesia Tray	Anago, Inc.	CAZ	Class II	1993-07-06
K930160	Illinois Sternal/iliac Aspiration Needle	Boston Scientific Corporation	GDM	Class I	1993-07-06
K926124	Cyto-Stat/coulter Clone Cd3 (Igg1)-Fitc/b4-Rd1 Mon	Coulter Corp.	GKZ	Class II	1993-07-06
K925363	Hypoallergenic Multi-Comfort Examination Gloves	Perusahaan Intan Emas Sdn. Bhd.	LYY	Class I	1993-07-06
K924897	Xenon Endoscopic Illuminator, Model Xei-300	Medical Devices Inc.	GCT	Class II	1993-07-06
K922918	Barrier Saf-Te Hydrogel Drape	Johnson & Johnson International	KKX	Class II	1993-07-06
K932197	Custom Anesthesia Circuits	Life Shield Healthcare Products, Inc.	CAI	Class I	1993-07-02
K932196	Coaxial Circuits	Life Shield Healthcare Products, Inc.	CAI	Class I	1993-07-02
K932195	Adult Gas Sampling Circuits	Life Shield Healthcare Products, Inc.	CAI	Class I	1993-07-02
K932194	Pediatric Gassampling Circuits	Life Shield Healthcare Products, Inc.	CAI	Class I	1993-07-02
K932193	Pediatric Temperature Monitoring Circuits	Life Shield Healthcare Products, Inc.	CAI	Class I	1993-07-02
K932192	Pediatric Anesthesia Circuits	Life Shield Healthcare Products, Inc.	CAI	Class I	1993-07-02
K932191	Breathing Bags	Life Shield Healthcare Products, Inc.	BTC	Class I	1993-07-02
K932190	Adult Temperature Monitoring Anesthesia Circuits	Life Shield Healthcare Products, Inc.	CAI	Class I	1993-07-02
K932058	Beltone Optima 2000 Ite Hearing Aid	Beltone Electronics Corp.	ESD	Class I	1993-07-02
K931881	In the Canal Aid Otosonic Acs II with Srr	Beltone Electronics Corp.	ESD	Class I	1993-07-02
K931256	Seidel Humeral Locking Nail	Howmedica Corp.	HSB	Class II	1993-07-02
K930957	Zefon Gas Sampling Lines	Zefon Medical Products	CCK	Class II	1993-07-02
K930895	Shiley Fenestrated Reusable Inner Cannula, Modif	Mallinckrodt Medical Tpi, Inc.	JOH	Class II	1993-07-02
K930670	Phyaction 787	Verimed Holdings, Inc.	IPF	Class II	1993-07-02
K930328	Navigator & Traveler Evoked Postential Product	Bio-Logic Systems Corp.	IKN	Class II	1993-07-02
K930307	Intelect 222 P	Chattanooga Group, Inc.	IMI	Class II	1993-07-02
K930196	Cepti-Seal i.v. Prep Kit	Medi-Flex Hospital Products, Inc.	LRS	Class II	1993-07-02
K930186	Intertron 6000/6100	Williams Healthcare Systems, LLC.	IMI	Class II	1993-07-02
K930158	Bone Marrow Biopsy Procedure Tray	Boston Scientific Corporation	GAA	Class I	1993-07-02
K925908	Ap01 and Ap02	Surgical Laser Technologies, Inc.	GEX	Class II	1993-07-02
K925214	Shave Prep Trays (Non-Sterile)	American Healthcare Supply Co., Inc.	LRO	Class II	1993-07-02
K924944	Instant in-Dwell Nasal Suct Tamp/allevia Nasal Tra	Westmed Intl.	EMX	Class I	1993-07-02
K924538	IV Start Kit	Cml, Inc.	LRS	Class II	1993-07-02
K924134	Leisegang Laparoscopic Irrigation System/access	Leisegang Medical, Inc.	GCS	Class II	1993-07-02
K923905	Wound Dressing Kit	Kit Pak, Inc.	MCY	Class II	1993-07-02
K923782	Transfer Set	Pacific Device, Inc.	LHI	Class II	1993-07-02
K922839	Mid-Canada Medical	Mid-Canada Medical	IMI	Class II	1993-07-02
K922179	Catheter Insertion Tray	Medcare Custom Packaging, Inc.	FMI	Class II	1993-07-02
K921546	Vasovasostomy Set	Cook Incorporated	KOA	Class I	1993-07-02