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 3125 of 3528

510(k) clearances, page 3125 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K833017	Serum Iron & Tibc#65084 & 65085	EMD Millipore Corporation	JIY	Class I	1983-11-03
K832923	Ambulatory Insulin Infusion Pump	Caridac Pacemakers, Inc.	FRN	Class II	1983-11-03
K832918	Pregna-Tec	Medilab Corp.	JHJ	Class II	1983-11-03
K832866	Hemo-Dial	Cmi Pharmaceuticals, Inc.	KPO	Class II	1983-11-03
K832827	Corpuls 300	Automated Medical Products Corp.	LDD	Class II	1983-11-03
K832772	Saturn-24Hr. Holter Scanner	Hittman Medical Systems	DSI	Class II	1983-11-03
K832767	Advantage #1700	Revvity Health Sciences, Inc.	CCK	Class II	1983-11-03
K832755	Infusion Pump & IV Sets #4000	Omni-Glow, Inc.	FRN	Class II	1983-11-03
K832744	Starlyte	Electro-Nucleonics Laboratories, Inc.	JGS	Class II	1983-11-03
K832698	Angioscopy Catheter	American Edwards Laboratories	LYK	Class II	1983-11-03
K832476	Silicone Soft-Pak Epistaxis Catheter	Axiom Medical, Inc.	ENW	Class I	1983-11-03
K832324	Thermal Dilution Catheter	Catheter Corp. of America	DYG	Class II	1983-11-03
K831946	Surgical Drill-Electric-Handpiece	Entronics	ERL	Class II	1983-11-03
K831877	Arf 850 E	W.E. Leder Enterprises, Inc.	CBK	Class II	1983-11-03
K831696	Portable Defibrillator Monitor 74Drk	Honeywell, Inc.	LDD	Class II	1983-11-03
K831397	French Intra-Aortic 9.5 Balloon on Kon	Datascope Corp.	DSP	Class II	1983-11-02
K831307	Pecor 8.5 French Iab on a Datascope	Datascope Corp.	DSP	Class II	1983-11-02
K833388	Iron Stain Procedure Ht20	Sigma Chemical Co.	LED	Class I	1983-10-31
K833332	Schultz Endhold	Polyclinic Medical Center	JAY	Class I	1983-10-31
K833295	Wescor 7100 Aerospray Slide Stainer	ELITechGroup Inc	KPA	Class I	1983-10-31
K833293	Leider Feeding Tube W/hydromer Lubr	Biosearch Medical Products, Inc.	KNT	Class II	1983-10-31
K833273	Masson Trichrome Stain Ht15	Sigma Chemical Co.	ICN	Class I	1983-10-31
K833269	Respir Gard Bacteria Filter	Marquest Medical Products, Inc.	CAH	Class II	1983-10-31
K833268	Endoscopic Overtube	Mill-Rose Laboratory	FED	Class II	1983-10-31
K833245	Security Stretch Brief-Medical	Mb Products, Ltd.	KNX	Class II	1983-10-31
K833187	Hall Osteon	Amsco Co.	GET	Class I	1983-10-31
K833185	Acetone Alcohol Prep Pad	Aplicare, Inc.	LKB	Unclassified	1983-10-31
K833183	Aplicare One Acetone Alcohol Swabstick	Aplicare, Inc.	LKB	Unclassified	1983-10-31
K833177	Glossectomy Feeding Spoons	Maddak, Inc.	ILC	Class I	1983-10-31
K833167	Trichrome Stain Lg Solution	Sigma Chemical Co.	LED	Class I	1983-10-31
K833141	One Time Acetone/alcohol;swab Sticks	Acme United Corp.	LKB	Unclassified	1983-10-31
K833125	Hobbs Medical Grasping Forceps	Hobbs Medical, Inc.	OCZ	Class II	1983-10-31
K832966	Flexiflo Enteral Feeding Tube	Abbott Medical	KNT	Class II	1983-10-31
K832924	Venous Reservoir	Shiley, Inc.	DTN	Class II	1983-10-31
K832880	Tracheostomy Care Trays	Packaging Technologies, Inc.	JOL	Class II	1983-10-31
K832869	Motility Measurement Sys Mms-100	Narco Bio-Systems	FFX	Class II	1983-10-31
K832813	Tandem-E Thyroid Stimulating Hormone Kit	Hybritech, Inc.	JLW	Class II	1983-10-31
K832542	i.v. Administration Set	Research Industries Corp.	FPA	Class II	1983-10-31
K832442	Electro-Acuscope	Kenneth J. Purcell	GZJ	Class II	1983-10-31
K832416	Axiom Hydromer Wound Drains	Axiom Medical, Inc.	GBS	Class I	1983-10-31
K832368	Changing Method of Sterility Release	Devon Industries, Inc.	EMF	Class I	1983-10-31
K832318	Isolation Bag 3M	3M Company	KGY	Class I	1983-10-31
K832270	Goat Anti-Human Lamba	Gelco Diagnostics, Inc.	DEH	Class II	1983-10-31
K832267	Fitc Goat Anti-Human Lamba	Gelco Diagnostics, Inc.	DES	Class II	1983-10-31
K832266	Fitc Goat Anti-Human Kappa Affinity	Gelco Diagnostics, Inc.	DFH	Class II	1983-10-31
K832265	Fitc Goat Anti-Human Igm H Chain	Gelco Diagnostics, Inc.	DFT	Class II	1983-10-31
K832263	Fitc Goat Anti-Human Iga a Chain	Gelco Diagnostics, Inc.	CZP	Class II	1983-10-31
K832262	Fitc Goat Anti-Human Immunoglobulins	Gelco Diagnostics, Inc.	CZN	Class II	1983-10-31
K832260	Goat Anti-Human Kappa Affinity	Gelco Diagnostics, Inc.	DEO	Class II	1983-10-31
K832258	Goat Anti-Human Igg Y Chain Specific	Gelco Diagnostics, Inc.	DEW	Class II	1983-10-31