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 2767 of 3530

510(k) clearances, page 2767 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872823	Delta Scrub	Pacific Biosystems, Inc.	GEC	Class I	1988-01-07
K874930	Model 366-12 Adaptaid(tm) Step-Down Adapter	Intermedics, Inc.	DTB	Class III	1988-01-06
K874643	Kirschner Neer-III Modular Proximal Humerus	Kirschner Medical Corp.	HSD	Class II	1988-01-06
K874609	Zeiss Visulas Argon Laser	Carl Zeiss, Inc.	HQF	Class II	1988-01-06
K874568	Hi-Lo Temp(r) Model 8700 Patient Temp Monitor	Mallinckrodt Critical Care	FLL	Class II	1988-01-06
K874525	Modified Foley Catheter/temperature Sensor	Mon-A-Therm, Inc.	KOD	Class II	1988-01-06
K874524	Modified Subcutaneous Temperature Sensor	Mon-A-Therm, Inc.	FLL	Class II	1988-01-06
K874523	Modified Tympanic & Esophageal/rectal Temp. Sensor	Mon-A-Therm, Inc.	FLL	Class II	1988-01-06
K874521	Modified Thermal Well Temperature Sensor	Mon-A-Therm, Inc.	FLL	Class II	1988-01-06
K874520	Modified Airway Temperature Sensor	Mon-A-Therm, Inc.	FLL	Class II	1988-01-06
K874467	Set, Administration Intravascular	Kendall Mcgaw Laboratories, Inc.	FPA	Class II	1988-01-06
K873884	Ivac Model 560+ Series Volumetric Infusion Pump	Y	FRN	Class II	1988-01-06
K873748	Rica(tm)-Ring Intest. Compress. Staple Anastom Kit	Deknatel, Inc.	GDW	Class II	1988-01-06
K873746	Auto Syringe Model As20g Infusion Pump	Baxter Healthcare Corporation	FRN	Class II	1988-01-06
K873667	Pall Leukocyte Removal Filter, Platelets	Pall Biomedical Products Co.	CAK	Class II	1988-01-06
K873666	Pall Leukocyte Removal Filter, Blood	Pall Biomedical Products Co.	CAK	Class II	1988-01-06
K873660	Roper-Tuke Elbow	Mizuho Orthopedic Systems Inc	JDB	Class II	1988-01-06
K873443	Ultraspot Micromanipulator	Cooper Lasersonics, Inc.	GEX	Class II	1988-01-06
K872953	Disposable i.v. Administration Set	Mac Lee Medical Products	FPA	Class II	1988-01-06
K872928	Lp-3000 High Resolution Electrocardiograph	Fidelity Medical, Inc.	DQK	Class II	1988-01-06
K872658	Model 980-Cardioscope at-3 Electrocardiograph	Del Mar Avionics	DPS	Class II	1988-01-06
K871881	Model 3000 Infusion Pump	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1988-01-06
K874941	Biotrol Bicarbonate (CO2) UV Hp)	Biotrol, USA, Inc.	KHS	Class II	1988-01-05
K874933	Mug-Indole Disc	Scott Laboratories, Inc.	JTO	Class I	1988-01-05
K874897	Sakura Drs-60 Automatic Slide Stainer	Sakura Finetek USA Inc	KPA	Class I	1988-01-05
K874856	Emit Convenience Pack: Phenytoin Assay	Syva Co.	DIP	Class II	1988-01-05
K874849	Prospect/giardia	Alexon Biomedical, Inc.	KHW	Class II	1988-01-05
K874810	Reference Assayed Chemistry Control Serum	Biotrol, USA, Inc.	JJY	Class I	1988-01-05
K874772	Dc-Trol Level 1 or 2	Diagnostic Chemicals, Ltd. (USA)	JJY	Class I	1988-01-05
K874704	Reflotron (R) Amylase	Boehringer Mannheim Corp.	JFJ	Class II	1988-01-05
K874702	Revised Labeling for Syva Barbiturate Assays	Syva Co.	DIS	Class II	1988-01-05
K874587	Paramax Urine/csf Calibrator	Baxter Healthcare Corporation	JIX	Class II	1988-01-05
K874532	Blood Urea Nitrogen	Catachem, Inc.	CDW	Class II	1988-01-05
K874436	Fluid Sampling Pack	U.S. Mfg. & Management, Inc.	KSS	Class I	1988-01-05
K874427	Qbc System Hemoglobin	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1988-01-05
K874413	Reagent a and Reagent B	Seradyn, Inc.	JIX	Class II	1988-01-05
K874373	Pt Pro-Clot	Probe-Tek, Inc.	JBR	Class II	1988-01-05
K874332	MRI Stretcher	Atomic Products Corp.	FPO	Class II	1988-01-05
K874207	The Purple Iris(tm) Cytopathology Workstation	Intl. Remote Imaging Systems	IBJ	Class I	1988-01-05
K874190	Cell Counting Grid Graticule	Portable Medical Laboratories, Inc.	IBJ	Class I	1988-01-05
K874033	Irma-Count Hcg W/mono. Antibodies Rkcg1,5,x	Siemens Healthcare Diagnostics Inc.	JHI	Class II	1988-01-05
K873893	Lumicon	Hamilton Co	JJQ	Class I	1988-01-05
K873371	Urinary Free Catecholamines & Metanephrines (Hplc)	Bio-Rad	CHQ	Class I	1988-01-05
K872774	Betatron IV System	Cardiac Pacemakers, Inc.	FRN	Class II	1988-01-05
K872617	Ebv-Ea Test	Gull Laboratories, Inc.	LSE	Class I	1988-01-05
K874966	Tuning Forks	Solway, Inc.	GWX	Class I	1988-01-04
K874926	Kodak Remote Alarm Unit	Eastman Kodak Company	IXW	Class II	1988-01-04
K874706	Modified Simpson Peripheral Atherocath	Devices for Vascular Intervention, Inc.	LIT	Class II	1988-01-04
K874430	Needle Container	American Medical Technology, Inc.	FMI	Class II	1988-01-04
K874367	Various Cardiac Cryoprobes Having Dia. & Cos. Diff	Spembly Medical, Ltd.	HQO	Class II	1988-01-04