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 2667 of 3530

510(k) clearances, page 2667 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884740	Euro-Med Light Touch Biopsy Punch	Buckman Co., Inc.	EME	Class I	1989-03-06
K884106	Supervisory Telemetry Arrhythmia Terminal	Siemens Medical Solutions USA, Inc.	DSI	Class II	1989-03-06
K883158	Respiratory Airway Tube Monitor (Ratm)	Vascucare, Inc.	BZQ	Class II	1989-03-06
K890648	Malis Bipolar Cord/irrigation Tubing Set	Valley Forge Scientific Corp.	GEI	Class II	1989-03-03
K890563	Spq(tm) Antibody Reagent Set II for Trf	Atlantic Antibodies	DDG	Class II	1989-03-03
K890311	Kosan Angel Latex Surgical Gloves (Sterile)	Kosan Far East Ent., Ltd.	KGO	Class I	1989-03-03
K890189	Agen Dimertest Eia	Agen Biomedical, Ltd.	DAP	Class II	1989-03-03
K885281	Vamp Venous/arterial Blood Management Protection	Baxter Healthcare Corporation	KRA	Class II	1989-03-03
K885045	Pharmaclens Low Abrasion Wound Sponge/brush	Baxter Healthcare Corporation	FRO	Unclassified	1989-03-03
K884103	Remote Vacuum Booster System, 7600 Series	Boehringer Laboratories, LLC	GCX	Class II	1989-03-03
K884025	Circon Acmi Bicap II Therapeutic System Bc-200	Circon Acmi	KNS	Class II	1989-03-03
K882643	Am Tm Syrgical Drapes	Henley Intl.	KKX	Class II	1989-03-03
K882401	Stony Brook Model Eecp-Mc1	Stony Brook Trading and Development Corp.	DRN	Class II	1989-03-03
K890723	Lancer - Modular Power Base	Everest & Jennings, Inc.	ITI	Class II	1989-03-02
K890508	Wellshire Emlink Model 1000	American Executive Technology	DXH	Class II	1989-03-02
K890492	Precept-Pt(tm) Microsensor Pressure Monitor Cath.	Endosonics Corp.	DXO	Class II	1989-03-02
K890353	Smds460 Surgical Monitor Display System	Vidco, Inc.	DXJ	Class II	1989-03-02
K890299	Kontron Pulse Oximeter 7840	Kontron Instruments, Inc.	DQA	Class II	1989-03-02
K890199	Dentocult Sm-Strip Mutans	Orion Corp.	JSI	Class I	1989-03-02
K890024	Sarns Vent Catheter	3M Company	DWF	Class II	1989-03-02
K885317	Lyme Elisa Test System	Zeus Scientific LLC	LSR	Class II	1989-03-02
K884822	Model Ox-1 Oxygen Saturation Module	Colin Medical Instruments Corp.	DQA	Class II	1989-03-02
K884592	Astro Trace (Model at-01)	The le Blanc Corp.	DSA	Class II	1989-03-02
K883848	Kmi Oxy-Ban	Knight Medical, Inc.	KPJ	Class II	1989-03-02
K882585	Cavrolab	Life-Tech Intl., Inc.	IYN	Class II	1989-03-02
K890750	Kodak X-Omatic Ra Cassette	Eastman Kodak Company	IXA	Class II	1989-03-01
K890385	Midwifery/obstetrical Forceps	Kinetic Medical Products	HDA	Class II	1989-03-01
K890346	Intertech Universal Hydrophobic Filter	Intertech/Ohio	CAH	Class II	1989-03-01
K885339	Flow Thru 16,18,20,22 Fr Replace. Gastro Tube Kit	Superior Healthcare Group, Inc.	KNT	Class II	1989-03-01
K885194	Kotex Security Tube Tampons	Kimberly-Clark Corporation	HEB	Class II	1989-03-01
K885128	Widex Bte Hearing Aid Model Q8	Widex Hearing Aid Co., Inc.	ESD	Class I	1989-03-01
K885007	Cimpat S Temporary Dental Cement	Specialites Septodont	EMA	Class II	1989-03-01
K884868	Obstetrical Safety System	Buckman Co., Inc.	KNC	Class II	1989-03-01
K884399	Standard Latex Condom	Schmid Laboratories, Inc.	HIS	Class II	1989-03-01
K882080	Model Number (Tbd) Toco Data Telephone Trans. Sys.	Aequitron Medical, Inc.	HFM	Class II	1989-03-01
K871358	Sensations Brand Condoms	Apex Medical Technologies, Inc.	HIS	Class II	1989-03-01
K890685	Bard Umbilical Vessel Catheter	C.R. Bard Inc	FOS	Class II	1989-02-28
K890653	Ultima Wheelchair Cushion	Clark Pillow Co., Inc.	IMP	Class I	1989-02-28
K890620	Stick-Gard Safety Needle	Ziehm International, Inc.	FMI	Class II	1989-02-28
K890551	Urinary Drainage Unit	Consolidated Products & Services, Inc.	KNX	Class II	1989-02-28
K890550	Cp&s Disposable Urinary Legbag (Medium & Large)	Consolidated Products & Services, Inc.	KNX	Class II	1989-02-28
K890544	Shapiro Cutter	H.S. Intl. Co., Inc.	HQE	Class II	1989-02-28
K884995	Siemens Pacs/1-B (Optical Disk Option)	Siemens Gammasonics, Inc.	LLZ	Class II	1989-02-28
K884989	Neviscan Model N - 100	Special Products, Inc.	HKI	Class II	1989-02-28
K884556	Dreyer Curved Endoilluminator	Advanced Surgical Products, Inc.	HQE	Class II	1989-02-28
K884527	Zinetics(r) Emc	Zinetics Medical, Inc.	KLA	Class II	1989-02-28
K884415	Ep-100 (Series)	Stereotactic Medical Systems, Inc.	FPD	Class II	1989-02-28
K884379	Maglinte Enteroclysis Catheter	Lafayette Pharmacal, Inc.	FGD	Class II	1989-02-28
K884141	Monoplace Hyperbaric Extension Set (L 11055)	Abbott Medical	FPA	Class II	1989-02-28
K883873	Infusion Fluid Warmer	PMT Corp.	LGZ	Class II	1989-02-28