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 3085 of 3528

510(k) clearances, page 3085 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K841206	Non-Selective & Differential	Smith River Biologicals	JSH	Class I	1984-04-17
K841204	Multiple Biochemical Test	Smith River Biologicals	JSE	Class I	1984-04-17
K841148	Mini Pecg-Modification	Intersect Systems, Inc.	DPS	Class II	1984-04-17
K841123	Dressing Change Tray	Medcare Products	FRG	Class II	1984-04-17
K841079	William Harvey H-4700 Filter/cardio	C.R. Bard Inc	DTN	Class II	1984-04-17
K841071	Pressure Manometer	Interventional Medical, Inc.	DQX	Class II	1984-04-17
K841032	Holder for Models Af-10,1025,1040,5	American Bentley	KRI	Class I	1984-04-17
K840997	Battery Powered Patient Lift	Invacare GmbH	FSA	Class I	1984-04-17
K840958	Deseret Long Term Indwelling Catheter	Parke-Davis Co.	LJS	Class II	1984-04-17
K840923	Angiography Needle W/wo Connection	Dlp, Inc.	DYB	Class II	1984-04-17
K840919	Daypak Sys VII Catheter Care Kit	Creative Care Systems, Inc.	KLK	Class II	1984-04-17
K840918	Micro Span Transcutaneous Oxygen Monit	Biochem International, Inc.	KLK	Class II	1984-04-17
K840915	Dimix Container for Parneteral Nutrit	Gil-Med Industries C/O Kegan & Kegan, Ltd.	KPE	Class II	1984-04-17
K840914	Argyle Tapered Vascular Shunt	Sherwood Medical Co.	DWF	Class II	1984-04-17
K840876	Phadebas Rast Test -Allergen Discs	Pharmacia, Inc.	DHB	Class II	1984-04-17
K840843	Potassium Chloride Tablets	Bionostics, Inc.	CHL	Class II	1984-04-17
K840839	Mmg Foley Catheter	Medical Technologies of Georgia	KOD	Class II	1984-04-17
K840767	Haemofuge a. Biofuge a. & B	Heraeus-Christ GmbH	JPI	Class II	1984-04-17
K840749	Gast Stat Monitoring System	Cardiovascular Devices, Inc.	DTY	Class II	1984-04-17
K840740	Circuit Breathing	Marquest Medical Products, Inc.	CAI	Class I	1984-04-17
K840685	Porphyrin Test Agar	Remel Co.	JSF	Class I	1984-04-17
K840675	Cor-Temp-Temp. Monitor	Product Research Organizations,Inc.	FLL	Class II	1984-04-17
K840658	Qbc Centrifugal Hematology Analyz	BD Becton Dickinson Vacutainer Systems Preanalytic	GKL	Class II	1984-04-17
K840643	Harris-Galante Porous Total Hip Sys	Zimmer GmbH	JDI	Class II	1984-04-17
K840612	Pediatric Arterial Blood Filter	American Bentley	DTM	Class II	1984-04-17
K840560	Neonatal Physiological Monitor 903	Novametrix Medical Systems, Inc.	DRT	Class II	1984-04-17
K840548	Resil	Parker Laboratories, Inc.	EBI	Class II	1984-04-17
K840490	Fluid Removal Assembly	Ackrad Laboratories	FMF	Class II	1984-04-17
K840458	Biotis Abnormal Clinical Chem Serum-	Otisville Biotech, Inc.	JJY	Class I	1984-04-17
K840450	Shiley Prebypass Filter	Shiley, Inc.	KRJ	Class II	1984-04-17
K840443	Retrograde Infusion Set 3Ml & 6Ml-	Tico Medical Instruments, Inc.	FPA	Class II	1984-04-17
K840338	Haemophilus I.d. II Triplate	Remel Co.	JSI	Class I	1984-04-17
K840298	Mca in the Ear Custom Hearing Aid	Maico Hearing Instruments, Inc.	ESD	Class I	1984-04-17
K840281	Angiographic Drape Packs	Medrad, Inc.	DXT	Class II	1984-04-17
K840274	Cardiofax ECG 6543	Nihon Kohden America Inc	DRS	Class II	1984-04-17
K840246	Mini-Defibrillator 280/4	Life Science Instrumentation, Inc.	LDD	Class II	1984-04-17
K840240	Microfuse Intravenous Catheter Set	Norton Performance Plastics Corp.	DQY	Class II	1984-04-17
K834597	Alpha Mass Storage Cardule 1895	Spacelabs, Inc.	DSI	Class II	1984-04-17
K834397	Holter Cardiography Sys 6201	Instruments for Cardiac Research	DSI	Class II	1984-04-17
K834134	Sarns 8.0 Soft Arc Cannula	3M Health Care, Sarns	DWF	Class II	1984-04-17
K834032	Rubaquick Diagnostic Kit	Abbott Medical	GOL	Class II	1984-04-17
K833997	Co-Set	American Edwards Laboratories			1984-04-17
K833884	Isotec Dispos. Pressure Transducer	Delta Medical Industries			1984-04-17
K833645	Contrast Media Inject. Set Cms	Gish Biomedical, Inc.	DXT	Class II	1984-04-17
K833497	Cooper Medical Model 770	Cooper Medical, SRL	LLF	Class III	1984-04-17
K833349	Event Tape Recorder 8293	Aequitron Medical, Inc.	DSH	Class II	1984-04-17
K833348	Respiration/8100-Heart Rate Recorder	Aequitron Medical, Inc.	DSH	Class II	1984-04-17
K832723	Digital Sphgmomanometer Ua-271	Copal, Inc.	DXN	Class II	1984-04-17
K832722	Digital Sphygmomanometer Ua-251	Copal, Inc.	DXN	Class II	1984-04-17
K823234	Radiation Sterilization of Surg. Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic			1984-04-17