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 2026-10-26, 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 2719 of 3530

510(k) clearances, page 2719 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882600	Hemocue Hemoglobin Calibrator	React and Co.	KRZ	Class II	1988-07-18
K882530	Tape Strung Tonsil Sponge	Ormed Mfg., Inc.	EFQ	Unclassified	1988-07-18
K882529	Butcher Strung Tonsil Sponge	Ormed Mfg., Inc.	EFQ	Unclassified	1988-07-18
K882528	Cylindrical Sponge	Ormed Mfg., Inc.	EFQ	Unclassified	1988-07-18
K882527	Gauze Sponge	Ormed Mfg., Inc.	EFQ	Unclassified	1988-07-18
K882520	Shoulder Bolster, Knee, Ankle & Leg Support Pads	Karlin Technology, Inc.	LWG	Class I	1988-07-18
K882501	Accufibrin(tm) Blood Collection System Af100	Terumo Medical Corp.	GIM	Class II	1988-07-18
K882485	Diversi-Kit	Intl. Cancer Screening Laboratories, Inc.	LIO	Class I	1988-07-18
K882479	26Mm Diameter Hancock* Trocar Blade and Tip	Medtronic Blood Systems, Inc.	DWS	Class I	1988-07-18
K882438	Constant Current Peripheral Nerve Stim. #Ns252	Fisher & Paykel Healthcare, Inc.	BXN	Class II	1988-07-18
K882371	Soc Slide Culture System	The Cancer Center at Wadley Institutes	JXC	Class I	1988-07-18
K882341	Quick Connect T Adaptor	Thayer Medical Corportation	BZO	Class I	1988-07-18
K882324	Steth-Shield Accessory to a Stethoscope	Steth-Shield, Inc.	LDE	Class I	1988-07-18
K882299	Sceptor Gram-Negative Urine Isolate Mic/id Panel	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-07-18
K882286	Expansion Coupler & Manual Drill as Accessory Set	Metatech Corp.	GWM	Class II	1988-07-18
K882275	Sterile Pack (Procedural Tray/kits)	East Texas Lighthouse for the Blind	LRP	Class I	1988-07-18
K882073	Spinal Needle	Karlin Technology, Inc.	GDM	Class I	1988-07-18
K881939	Sirecust 1280/1281 & 960/961 Patient Monitors	Siemens Medical Electronics	DPS	Class II	1988-07-18
K881883	Satlite+/pb251+ Pulse Oximeter	Datex Division Instrumentarium Corp.	DQA	Class II	1988-07-18
K881853	Franz Catheter	Ep Technologies, Inc.	DRF	Class II	1988-07-18
K881837	Optima Mpt Series III Pacemaker, 5281D and 5282D	Telectronics, Inc.	DXY	Class III	1988-07-18
K881820	Edentec Model 2800/2801 Oximeter/pulse Oximeter	Edentec Corp.	DQA	Class II	1988-07-18
K881812	Aero-Mist Nebulizer	Cadema Medical Products, Inc.	IYT	Class II	1988-07-18
K881749	Straight-Line Finish for Implantable Pulse Genera.	Medtronic, Inc.	GXY	Class II	1988-07-18
K881589	14X14 Multiformat Spot Filmer, No. 6650.400	Continental X-Ray Corp.	IXL	Class II	1988-07-18
K881464	Multimode(tm) Interface Sys. for Everest & Jenning	Dufco Electronics, Inc.	ITI	Class II	1988-07-18
K881463	Multimode(tm) Power Module System	Dufco Electronics, Inc.	ITI	Class II	1988-07-18
K881462	Unimode(tm) Power Module System	Dufco Electronics, Inc.	ITI	Class II	1988-07-18
K881461	Multimode(tm) Interface System for Meyra Wheelch.	Dufco Electronics, Inc.	ITI	Class II	1988-07-18
K880936	Triad-Ep	Cardiotronics, Inc.	DRO	Class II	1988-07-18
K874473	Adac Model Arc-St, Pc Style Data Processing System	Philips North America LLC	JWM	Class II	1988-07-18
K882692	Model P20/p21 in-the-Ear Hearing Aid	Maico Hearing Instruments, Inc.	ESD	Class I	1988-07-15
K882634	Visual Contrast Sensiti., Potential Acuity&glare	Vistech Consultants, Inc.	HOX	Class I	1988-07-15
K882576	Acid Etch Gel	Pulpdent Corp. of America	EBF	Class II	1988-07-15
K882400	Amorphus Silk by Dentrax	Dale T. Dupuis	EBF	Class II	1988-07-15
K882131	Nose Brace	Allied Advanced Technologies (Aat)	LWF	Class I	1988-07-15
K881958	Jedmed Maxim ENT Cabinet	JEDMED Instrument Company	ETF	Class I	1988-07-15
K881918	Light-Cured Zionomer Cement	Den-Mat Corp.	EMA	Class II	1988-07-15
K881914	Cover Up	Parkell, Inc.	EMA	Class II	1988-07-15
K881890	Proviscem or Proviscell Eugenol-Free Dental Cement	Specialites Septodont	EMA	Class II	1988-07-15
K881804	Multi-Flex Table--Model 200	Slenderizers Equipment Mfg., Inc.	JFB	Class II	1988-07-15
K881757	Resubmitted Juniper T.m. Joint Distraction Forceps	Downs Surgical, Ltd.	ETN	Class II	1988-07-15
K881680	Ackrad H/s Procedure Tray	Ackrad Laboratories	HIG	Class II	1988-07-15
K880979	Marquest Sct 2000, Heated Humidification System	Marquest Medical Products, Inc.	BTT	Class II	1988-07-15
K880940	Amdent Model 830 Ultrasonic Scaler	Pathway Products, Inc.	ELC	Class II	1988-07-15
K880778	Medsurg Acute Dialysis Tray	Medsurg Industries, Inc.	LFJ	Class II	1988-07-15
K882583	Latex Exam Gloves, Non-Sterile	B und J Instruments	FMC	Class I	1988-07-14
K882535	Abbott Testpack(tm) Chlamydia Positive Control	Abbott Medical	LJC	Class I	1988-07-14
K882312	Model 3000 Nuclear Camera	Ohio Imaging, Inc.	IYX	Class I	1988-07-14
K882017	Respironics Suctioneasy	Respironics, Inc.	BSY	Class I	1988-07-14