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 2026-11-02, 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 2531 of 3531

510(k) clearances, page 2531 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K902114	Cuff-Mate 2 Endotracheal Cuff Inflator & Monitor	Diemolding Corp.	BSK	Class II	1990-07-18
K902080	Red Dot 2269 Infant Monitoring Electrode	3M Company	DRX	Class II	1990-07-18
K901819	Model 78834C Neonatal Pulse Oximeter (Sao2)	Hewlett-Packard Co.	DQA	Class II	1990-07-18
K901555	Model 1730 Neotrode with Attached Leadwire	Medtronic, Inc.	DRX	Class II	1990-07-18
K901232	Impraflo Autotransfusion Device	Impra, Inc.	CAC	Class II	1990-07-18
K900783	Mdi Adaptor	Hudson Oxygen Therapy Sales Co.	CAF	Class II	1990-07-18
K900722	Low Flow N2o/02o Microblender	Bird Products Corp.	BZR	Class II	1990-07-18
K900664	Disposable Cournand, Seldinger & One-Wall Needles	STERIMED, Inc.	DRC	Class II	1990-07-18
K900451	Vitalmax 800 Non-Invasive Vital Sign Monitor/pulse	Pace Tech, Inc.	DRT	Class II	1990-07-18
K900365	Pag Microprocessor-Controlled Module	Life Sciences Manufacturing, Inc.	DQC	Class I	1990-07-18
K896500	Cwd/ppg Module	Life Sciences Manufacturing, Inc.	JOM	Class II	1990-07-18
K902801	Beckman Total Bilirubin Triggered (Tb-T) Kit	Beckman Instruments, Inc.	CIG	Class II	1990-07-17
K902673	Hi Chem Total Protein/albumin Serum Range Lin Stnd	Hi Chem, Inc.	JJY	Class I	1990-07-17
K902671	Cobe Autologous Blood Salvage Reserv W/w/o Filter	Cobe Laboratories, Inc.	CAC	Class II	1990-07-17
K902560	Roche Cobas Ready Alkaline Phosphatase Reagent	Roche Diagnostic Systems, Inc.	CJE	Class II	1990-07-17
K902479	Calcium Reagent Code 7732, 7733, 7532 & 7432	Amresco, Inc.	CIC	Class II	1990-07-17
K902476	Calcium:arsenazo III	Amresco, Inc.	CJY	Class II	1990-07-17
K902414	Opti-Ray Sunglasses	Opti-Ray, Inc.	HQY	Class I	1990-07-17
K902235	Lvm Quality Control Serum	Ciba Corning Diagnostics Corp.	JJY	Class I	1990-07-17
K902208	Modified Ovugen	Biogenex Laboratories, Inc.	CEP	Class I	1990-07-17
K902194	Micro Dau Opiate Enzyme Immunoassay Kit	IMMUNOTECH s.r.o.	DJG	Class II	1990-07-17
K902147	Endocardial Screw-in Lead Model 1028T	Pacesetter Systems	DTB	Class III	1990-07-17
K901948	Cardisuny 501Biii	Graham-Field, Inc.	DPS	Class II	1990-07-17
K901947	Cardisuny 501Ab	Graham-Field, Inc.	DPS	Class II	1990-07-17
K901889	Fukuda Denshi Model Hj-310	Fukuda Denshi USA, Inc.	DXN	Class II	1990-07-17
K901762	Prefilled Flexible R.t. Containers W/ster. Sodium	Automatic Liquid Packaging, Inc.	BTT	Class II	1990-07-17
K901410	Technicon Ra-2000(Tm) System	Technicon Instruments Corp.	JJC	Class I	1990-07-17
K900822	Hydro-Sil(tm) Coated Guidewires	National-Standard Medical Products	DOX	Class II	1990-07-17
K900540	Tram Patient Monitor	Marquette Electronics, Inc.	DSI	Class II	1990-07-17
K900460	Modified Novoste Angiographic Catheter	Best Vascular, Inc.	DQO	Class II	1990-07-17
K900350	Leocor Corflo(tm) Pump	Leocor, Inc.	DXK	Class II	1990-07-17
K900311	Arterial Embolectomy Catheter	Impra, Inc.	DXE	Class II	1990-07-17
K900247	Cbm-3000/Cbm-2000/Cbm-7000 Blood Pressure System	Colin Medical Instruments Corp.	DXN	Class II	1990-07-17
K900220	Trans-Pace 100	Synchromed Corp.	DTE	Class II	1990-07-17
K897124	Small Vessel Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	1990-07-17
K896742	Focus J81f, J83f, J41f, J43f Pacing Leads	Ela Medical, Inc.	DTB	Class III	1990-07-17
K895520	Pagewriter Xli M1700a & Pagewriter Xl M1701a	Hewlett-Packard Co.	LOS		1990-07-17
K884120	Type 9240 Ecg/resp Syst Athena (Adult & Pediatic)	S & W Medico Teknik	BZQ	Class II	1990-07-17
K902897	Ubi Magiwel(tm) Anti-Ds-DNA Quantitative	United Biotech	LRM	Class II	1990-07-16
K902867	Chem-Chex Bilirubin	Streck Laboratories, Inc.	JJX	Class I	1990-07-16
K902773	Surgitek(r) Flexible Ureteroscopy Intro/sheath Set	Medical Engineering Corp.	FGB	Class II	1990-07-16
K902739	Pasco Mic and Mic/id Modified	Pasco Laboratories, Inc.	JWY	Class II	1990-07-16
K902699	Shape-Actio Urinalysis Controls(assayed & Unassay)	Actio, Inc.	JJW	Class I	1990-07-16
K902640	Dmac Indole Reagent	Api Analytab Products	JTO	Class I	1990-07-16
K902510	Cards O.s. Mono	Pacific Biotech, Inc.	KTN	Class II	1990-07-16
K902495	Acid Phosphatase Reagent Set	Tech Intl. Co.	CKB	Class II	1990-07-16
K902461	Meadox Surgimed Biopsy Gun and Needle	Meadox Surgimed, Inc.	KNW	Class II	1990-07-16
K902417	Bag, Urine	Gainor Medical Europe, Ltd.	KNX	Class II	1990-07-16
K902356	Kodak Ektachem Clinical Chemistry Slides (Sali)	Eastman Kodak Company	DKJ	Class II	1990-07-16
K902261	Ambu Spur (Single Patient Use Resuscitator) Infant	Ambu, Inc.	BTM	Class II	1990-07-16