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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3489 of 3526

510(k) clearances, page 3489 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770744	IV Set That Reverts to Kvo Rate	Abbott Medical	FPA	Class II	1977-05-26
K770583	Medi-Pak Lemon Glyceoin Swabs	General Medical Co.	KXF	Class I	1977-05-26
K770910	Medishield Cervical Collar	Fraser Sweatman, Inc.	HSS	Class I	1977-05-25
K770885	Hearing Aid, Series K-Behind-the-Ear	Maico Hearing Instruments, Inc.	ESD	Class I	1977-05-25
K770879	Bronchofiberscope, Fb-19A	Pilling Co.			1977-05-25
K770801	Microbio. Prod. Fluorescent Antibody	Pfizer Pharmaceuticals	GMY	Class I	1977-05-25
K770678	Elc-Thermo-System	Cutter Laboratories, Inc.	KXZ	Class III	1977-05-25
K770908	Prosthesis, Hip, Trapezoidal-28	Zimmer GmbH	JDI	Class II	1977-05-23
K770884	Elhctrocardiographic Connecting Wires	Tronomed, Inc.	DSA	Class II	1977-05-23
K770856	Prosthesis, Trapezium & Trapezium Trial	Depuy, Inc.			1977-05-23
K770853	Sterile Cotton	Stat Medical Corp.	FRL	Class I	1977-05-23
K770838	Anesthesia Breathing Circuit, Disposable	Ohio Medical Products	CAI	Class I	1977-05-23
K770828	Nebulizer Heater	Ohio Medical Products	CAF	Class II	1977-05-23
K770812	Handles, Light, Surgical, Steoile	Sybron Corp.	FQP	Class II	1977-05-23
K770647	Electrosurgical Grounding Cable	C.R. Bard Inc	GEI	Class II	1977-05-23
K770635	Protector, Heel & Elbow	Tecnol New Jersey Wound Care, Inc.	FMP	Class I	1977-05-23
K770633	Bracket Be 122-1	Instrumentation Industries, Incorporated	CAF	Class II	1977-05-23
K770631	Flex Arm Be 122, Clamp 122-27	Instrumentation Industries, Incorporated	JAY	Class I	1977-05-23
K770630	Adapter, Universal, Be 105-6	Instrumentation Industries, Incorporated	BZA	Class I	1977-05-23
K770629	Valve, Exhalation Be 115-4, 115-5	Instrumentation Industries, Incorporated	CBP	Class II	1977-05-23
K770628	Clamp Be-152	Instrumentation Industries, Incorporated	JAY	Class I	1977-05-23
K770627	Adapter, Valve, One Way Be-130-22	Instrumentation Industries, Incorporated	CBP	Class II	1977-05-23
K770595	Suture Removal Set	Abco Dealers, Inc.	JOK	Class I	1977-05-23
K770589	Filter, Intravenous W/auto Air Vent	Jelco Laboratories	FPA	Class II	1977-05-23
K770588	Cotton Ball Kit	American Hospital Supply	FRL	Class I	1977-05-23
K770579	Catheter, Urethral Pressure, Upe-10 & 12	Life-Tech Instruments, Inc.	FAP	Class II	1977-05-23
K770488	Isolation Gown	General Medical Co.	FYC	Class II	1977-05-23
K770813	Endogator	Aus-Tex Dental Mfg. & Design	EIC	Class I	1977-05-20
K770811	Adenovirus Group-Fa Labelled Preserum	Flow Laboratories, Inc.	GNY	Class I	1977-05-20
K770810	Varicella-Zoster Fa Labeled Preserum	Flow Laboratories, Inc.	GQX	Class II	1977-05-20
K770809	Measles-Fa Labeled Preserum (8-441 Rnf)	Flow Laboratories, Inc.	GOL	Class II	1977-05-20
K770808	Resp. Syncytial-Fa Labelled Preserum	Flow Laboratories, Inc.	GQG	Class I	1977-05-20
K770807	Adenovirus-Group Fa Labelled (8-651 RF)	Flow Laboratories, Inc.	GNY	Class I	1977-05-20
K770806	Varicella-Zoster Fa Labelled (8-321 RF)	Flow Laboratories, Inc.	GQX	Class II	1977-05-20
K770805	Measles-Fa Labelled (8-441 RF)	Flow Laboratories, Inc.	GOL	Class II	1977-05-20
K770804	Resp. Syncytial-Fa Labellhd (8-301-RF)	Flow Laboratories, Inc.	GQG	Class I	1977-05-20
K770785	Monitor, Respiratory, Two-Gas, Rdc	Research Development Corp.	KLA	Class II	1977-05-20
K770778	Maxi-Pads, Stayfree	Personal Products Co.	HHD	Class I	1977-05-20
K770758	Injection System, Mdc i.v.	Medical Development Co.	KZD	Class I	1977-05-20
K770697	Colposcope System	Richard Wolf Medical Instruments Corp.	HEX	Class II	1977-05-20
K770682	Sterilizer, Series 3000, Modification to	Castle Co.	FLE	Class II	1977-05-20
K770677	T-3 Ria Reagent Set	G.D. Searle and Co.	CDP	Class II	1977-05-20
K770676	T-4 Ria Reagent Set	G.D. Searle and Co.	CDX	Class II	1977-05-20
K770659	Rialyze Hpl (Ria)	Miles Laboratories, Inc.	JMF	Class II	1977-05-20
K770592	Cytology Fixative	Surgipath Medical Industries, Inc.	LEA	Class I	1977-05-20
K770829	Recording Unit, Model 1445	Scole Engineering Co.			1977-05-18
K770823	Audiometric Testing Sys., Series 500	Automated Testing Services, Ltd.	EWO	Class II	1977-05-18
K770786	Splints, Finger/toe	Depuy, Inc.	ILH	Class I	1977-05-18
K770790	Feedback Edr System Model Edr-100	Bio-Feedback Systems, Inc.	HCC	Class II	1977-05-10
K770783	Film Processor, Automatic	General Electric Co.	EGY	Class II	1977-05-10