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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2928 of 3529

510(k) clearances, page 2928 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860177	Allen Universal Stirrup	Edgewater Medical Equipment Systems	BWN	Class I	1986-02-11
K860172	Qwikspin (Tm)	Norfolk Scientific, Inc.	JQC	Class I	1986-02-11
K860142	Uric Acid Reagent Set (Colorimetric)	Sterling Diagnostics, Inc.	LFQ	Class I	1986-02-11
K860141	Stratus Procainamide Fluorometric Enzyme Immuno.	American Dade	LAR	Class II	1986-02-11
K860110	Glutamic Pyruvic Transaminase, Gpt(uv) Reagent Set	Technostics Intl.	CKA	Class I	1986-02-11
K860097	Therapeutic Drug (Tdm) Calibrator	Instrumentation Laboratory Co.	DIF	Class I	1986-02-11
K860096	Cpk Reagent Set (Colorimetric)	Sterling Diagnostics, Inc.	CGS	Class II	1986-02-11
K860074	Schultz Metacarpophalangeal Joint Prosthesis	Warsaw Orthopedic, Inc.			1986-02-11
K860044	Calcium (Cpc) Reagent Set	Sterling Diagnostics, Inc.	CIC	Class II	1986-02-11
K860021	Dimension(tm) Clinical Chemistry System	E.I. Dupont de Nemours & Co., Inc.	JJE	Class I	1986-02-11
K855228	Femoral Hemi-Hip Prostheses	Orthopaedic Device Corp.	KWL	Class II	1986-02-11
K855203	Glucolet Automatic Lancing Device for Obt. Blood	Miles Laboratories, Inc.	FMK	Class II	1986-02-11
K855149	Computing Spectrophotometer Bio-Chemistry Analyzer	Hyperion, Inc.	JJQ	Class I	1986-02-11
K855123	Kmw Hip Prosthesis Porous Coated	Kirkschner Medical Corp.			1986-02-11
K855080	Emds Glucose Test Pack Item 67656/95	Em Diagnostic Systems, Inc.	LFR	Class II	1986-02-11
K854987	Intra-Articulated Arthroscopic Power System	Richard Wolf Medical Instruments Corp.	HWE	Class I	1986-02-11
K854945	Magic No Boil B12/folate Radioimmunoassay	Ciba Corning Diagnostics Corp.	CDD	Class II	1986-02-11
K854812	Nelson-Jung Pleural Cath	Research Medical, Inc.	GBW	Class I	1986-02-11
K854770	Martin Laminar Osteosynthesis System	Advanced Biosearch Assn.	KWP	Class II	1986-02-11
K854669	S.l.t. Laser Delivery System for Yag Laser	Surgical Laser Technologies, Inc.	LNK	Class II	1986-02-11
K854472	Portalase 300 Carbon Dioxide Surg Laser Dermatolog	Minnesota Laser Corp.	GEX	Class II	1986-02-11
K854469	Portalase 200 Carbon Dioxide Surg Laser Dermatolog	Minnesota Laser Corp.	GEX	Class II	1986-02-11
K860143	Urine Diluent-for Use with Ion Selective Electrode	Reagent Laboratory, Inc.	JJP	Class I	1986-02-10
K860040	Hydrajust III Urological Table	Mallinckrodt Group, Inc.	KQS	Class I	1986-02-10
K855003	Beraha Biopsy Needles, 2N2730, 2N2731 & 2N2732	Travenol Laboratories, S.A.	KNW	Class II	1986-02-10
K854960	Disposable Manifold	Utah Medical Products, Inc	DTL	Class II	1986-02-10
K854862	Curity Ureteral Stent	The Kendal Co.	FAD	Class II	1986-02-10
K854843	Ma-1 Volume Ventialtor	Medtronic, Inc.			1986-02-10
K854841	Shiley Venous Reservoir	Shiley, Inc.	DTN	Class II	1986-02-10
K854734	Model 5320 Ted Sequential Comp. De. Comp. Limb Sle	Medasonics, Inc.	DRM	Class II	1986-02-10
K854652	Angiomed Ureteral Stone Dislodgers	Angiomed U.S., Inc.	FFL	Class II	1986-02-10
K854640	Modified Coronary Cardioplegia Adaptor	Shiley, Inc.	DWF	Class II	1986-02-10
K854571	Demand Flow Valve & Sonra W/nasal Mask	Gale E. Dryden	CBN	Class II	1986-02-10
K854511	Elecath Percutaneous Left Atrial Cannulation Set	Electro-Catheter Corp.	DQX	Class II	1986-02-10
K854487	Venous Return Cannula W/cuff 91039	Dlp, Inc.	DWF	Class II	1986-02-10
K854465	Link Contour Ribbed Hip Prostheses System	Link America, Inc.	JDI	Class II	1986-02-10
K854441	Stuart Gilman's Weight Loss Plan	Alpha Therapeutic Corp.	LDQ		1986-02-10
K854406	Tecan Robotic Sample Processor(rsp) #500	Tecan U.S.	JQW	Class I	1986-02-10
K860173	Vis-2000 Video System	Vistek Corp.	FWG	Class I	1986-02-07
K860065	Slush Pan Cover	O.R. Concepts, Inc.			1986-02-07
K860043	Wink-Ease Disposable Protective	Eye Pro Medical Products, Inc.	HQY	Class I	1986-02-07
K860018	Fischer Wire/pin Clamp	Buckman Co., Inc.	HXK	Class I	1986-02-07
K860017	Acromed Cancellous Bone Screw	Buckman Co., Inc.	HWC	Class II	1986-02-07
K860011	Nidek Ac-2000 Laser System	Nidek, Inc.	HQB	Class II	1986-02-07
K854871	Micro Surgical System	Mira, Inc.	HQE	Class II	1986-02-07
K854868	I/a - Vfe System II	Mira, Inc.	HQE	Class II	1986-02-07
K854507	Storz Mvs 19 & 20 Gauge Scleral Plugs	Storz Instrument Co.	LXP	Class II	1986-02-07
K854506	Storz Mvs 2.5Mm/4.0mm,6.0mm Infusion Cannula	Storz Instrument Co.	HMX	Class I	1986-02-07
K854470	Portalase 300 Carbon Dioxide Surg Laser Gynecologi	Minnesota Laser Corp.	HHR	Class II	1986-02-07
K854429	Acuson Needle Guide System	Acuson Computed Sonography	ITX	Class II	1986-02-07