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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2536 of 3530

510(k) clearances, page 2536 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K895867	Pancretec i.v. Model 5000 Infuser	Abbott Medical	FRN	Class II	1990-06-26
K895365	Md-2 Iontophoresis Unit	R. A. Fischer Co. Corp.	EGJ	Class II	1990-06-26
K894484	Audiotester Screening Audiometer	Prometex, Inc.	EWO	Class II	1990-06-26
K893769	Lifecare Micro Pump (Infusion Pump)	Abbott Medical	FRN	Class II	1990-06-26
K902332	Hall Modular Acetabular Reamer System	Zimmer GmbH	HWE	Class I	1990-06-25
K901765	Posteromedial Guide	Smith & Nephew Dyonics, Inc.	HRX	Class II	1990-06-25
K901215	700 Series Biomagnetometer	Biomagnetic Technologies, Inc.	OLX	Class II	1990-06-25
K900512	Siemens Elema Models 4020T and 4021T Adapters	Pacesetter Systems	DTD	Class II	1990-06-25
K896934	Knightwatch System	Createch Corp.	BZQ	Class II	1990-06-25
K896106	Rogozinski Spinal System, Add'l Components	Richards Medical Co., Inc.	KWP	Class II	1990-06-25
K902586	Gri Lasergraph(tm) ECG Paper	Gri Medical Products, Inc.	DSF	Class I	1990-06-22
K902521	Weevac 6 Infant Evacuation Stretcher	W. Murphy Ent., Inc.	FPP	Class I	1990-06-22
K902459	Latex Examination Gloves	Yue XI State Farms Latex Products United Corp.	LYY	Class I	1990-06-22
K902012	Vks-1 Video Keratoscope	Computed Anatomy, Inc.	HLQ	Class I	1990-06-22
K901919	Contact Molar Bands and Contour Strips	Ivoclar North America, Inc.	DZN	Class I	1990-06-22
K901916	Special Bond	Ivoclar North America, Inc.	EBF	Class II	1990-06-22
K901909	Silamat (Amalgamator)	Ivoclar North America, Inc.	EFD	Class I	1990-06-22
K901879	Intrasite Hydrocolloid Dressing (Revised Labeling)	Smith & Nephew United, Inc.	KGX	Class I	1990-06-22
K901878	Intrasite Gel (Labeling Revision)	Smith & Nephew United, Inc.	KMF	Class I	1990-06-22
K901877	Allevyn Dressing (Labeling Revised)	Smith & Nephew United, Inc.	KMF	Class I	1990-06-22
K901789	Paladon(r) 65	Kulzer GmbH	EBI	Class II	1990-06-22
K901664	Carefree(tm) Festiva Pantyshields	Personal Products Co.	HHD	Class I	1990-06-22
K901636	Diamond Nd:yag Ophthalmic Laser	Biovision, Inc.	GEX	Class II	1990-06-22
K901585	Ohmeda - Ohio(r) Care Plus Incubator	GE Healthcare	FMZ	Class II	1990-06-22
K901583	Shin Nippon Auto Refractometer Qr-007N	Soderberg, Inc.	HKO	Class I	1990-06-22
K901582	Dobbhoff Biliary Stent Set	Biosearch Medical Products, Inc.	FGE	Class II	1990-06-22
K901522	Olympic Smart Scale Pediatrics Model 50	Olympic Medical Corp.	FRW	Class I	1990-06-22
K901458	Nutricare Enfutec 1000 Enteral Feeding Pump	Clinical Systems, Inc.	LZH	Class II	1990-06-22
K901441	Albert Morton Urological Catheter	Transinternational Marketing Group	GBM	Class II	1990-06-22
K901427	Biliary Stone Retrieval and Occlusion Balloon	TeleMed Systems	FGE	Class II	1990-06-22
K901217	Tria-Sonic Ultra Sound Transmission Gel	H & P Industries, Inc.	JOT	Class II	1990-06-22
K900936	Non-Prescription Sunglasses	Barkley House, Inc.	HQY	Class I	1990-06-22
K900894	Medilase Series 2100 Endoscope	Medical Laser, Inc.	GCQ	Class II	1990-06-22
K900668	Acudata Indicatens Model 5Xs	Acudata Software	GZJ	Class II	1990-06-22
K900596	Acudata Indicatens Model 5A	Acudata Software	GZJ	Class II	1990-06-22
K900545	O-Ring Prosthetic Attachment Device	Calcitek, Inc.	DZE	Class II	1990-06-22
K900353	Shielded Piggyback IV Needle	Pascall Saringia Medical Corp.	FPA	Class II	1990-06-22
K900317	Pacemate Flow Directed Thermal Dilution Catheter	Elecath	KRB	Class II	1990-06-22
K897021	Martin-Hensley Segment Lens	Bruce W. Martin O.D. and Edward Hensley	HPX	Unclassified	1990-06-22
K896933	Ingress Technologies Auto Bx Biopsy Needle Gun	The Witmoore Group, Inc.	KNW	Class II	1990-06-22
K896932	Ingress Technologies Auto Bx Biopsy Needle	The Witmoore Group, Inc.	FCG	Class II	1990-06-22
K895857	Continuous Irrigation Resectoscope Syst/gynecology	Richard Wolf Medical Instruments Corp.	HIH	Class II	1990-06-22
K902600	The Companion Non-Electric Lift Chair	Innovative Medical Engineering, Inc.	INN	Class I	1990-06-21
K902485	Beckman Lambda Light Chain Reagent (Add'l Claims)	Beckman Instruments, Inc.	DEH	Class II	1990-06-21
K902484	Beckman Kappa Light Chain Reagent (Add'l Claims)	Beckman Instruments, Inc.	DFH	Class II	1990-06-21
K902462	Modified Qm300 Rheumatoid Factor Test	Kallestad Diag, A Div. of Erbamont, Inc.	DHR	Class II	1990-06-21
K902269	Electri-Cool(tm) Liquid-Circulat. Thermal Therapy	Seabrook Medical Systems, Inc.	ILO	Class II	1990-06-21
K902268	Pedia-Temp(tm) Liquid-Circulating Hypo-Hypertherm.	Seabrook Medical Systems, Inc.	ILO	Class II	1990-06-21
K901984	Ace Wire Tension Clamp	Buckman Co., Inc.	JEC	Class II	1990-06-21
K901600	Osseotite Irrigation Unit	Collagen Corp.	EFS	Class I	1990-06-21