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 3168 of 3528

510(k) clearances, page 3168 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K830544	Windsor Medical, Inc. 50-01-028	Windsor Medical, Inc.	FRN	Class II	1983-03-31
K830522	Stainless Steel Suture 316L	Sharpoint, Inc.			1983-03-31
K830515	Scotts Tap Water Substitute Concentrate	Surgipath Medical Industries, Inc.	KEQ	Class I	1983-03-31
K830490	Model 50-01-27	Windsor Medical, Inc.	FRN	Class II	1983-03-31
K830476	Or Prep Kit	Clinipad Corp.	FRG	Class II	1983-03-31
K830467	Tourniquet/latex Tourniquet	Primeline Industries, Inc.	GAX	Class I	1983-03-31
K830454	Ims Miniature Volumetric Infusion Pump	Ziehm International, Inc.	FRN	Class II	1983-03-31
K830368	Ambulatory Blood Pressure Monitor	Vita-Stat Medical Services, Inc.	DXN	Class II	1983-03-31
K830333	Abg Kits - Cms 4000 Series	Currie Medical Specialties, Inc.	CBT	Class I	1983-03-31
K830317	Infusion Pump Access. #60-01-5	Windsor Medical, Inc.	FRW	Class I	1983-03-31
K830315	Dual Channel Recorder #78574A	Hewlett-Packard Co.	DSF	Class I	1983-03-31
K830253	End Tidal CO2 Analyzer #411	Andros Incorporated			1983-03-31
K830029	Sirecust 400	Analogic Corp.	DSI	Class II	1983-03-31
K830025	Digital Subtraction Angiography Conven-	Medrad/Technology for People	DQO	Class II	1983-03-31
K823891	Model Ky Pacemaker Lead - Various	Oscor Inc.	DTB	Class III	1983-03-31
K823890	Model Zy Pacemaker Lead-Various	Oscor Inc.	DTB	Class III	1983-03-31
K823854	Medcare Suture Removal Trays	Medcare Products	FSM	Class I	1983-03-31
K823527	Subclavian Insertion Kit	Cunningham Woodland, Inc.	FMF	Class II	1983-03-31
K823511	EMG Biofeedback Device	Nemectron Medical, Inc.	HCC	Class II	1983-03-31
K823136	Oral Sponge	Amisplint			1983-03-31
K823057	Medicated Adhesive Strip	Cederroth, Inc. USA			1983-03-31
K830792	Pulsette 110 Transcutaneous Elec-Nerve	Bomed Medical Mfr., Ltd.	GZJ	Class II	1983-03-29
K830766	Abbott Patient Assist Device	Abbott Medical	FKX	Class II	1983-03-29
K830757	Hot/ice	Thermo Temp, Inc.	ILO	Class II	1983-03-29
K830739	Pro-Guard	Surgicot, Inc.	FRG	Class II	1983-03-29
K830729	C-Dak Artificial Kidney	Cordis US Corp.	KOC	Class II	1983-03-29
K830710	Argyle Silicone Salem Sump Tube	Sherwood Medical Co.	KNT	Class II	1983-03-29
K830709	Argyle Suction Catheters	Sherwood Medical Co.	BSY	Class I	1983-03-29
K830695	Beta-Cote B-Hcg Pregnancy Screening Sys	BD Becton Dickinson Vacutainer Systems Preanalytic	JHI	Class II	1983-03-29
K830689	Empty Dialysate Container Bb-69	Delmed, Inc.	FKX	Class II	1983-03-29
K830671	Thorax-Klex Chest Drainage Unit	C.R. Bard Inc	KDQ	Class II	1983-03-29
K830648	H1207	Hospal Medical Corp.	KDI	Class II	1983-03-29
K830647	H1210	Hospal Medical Corp.	KDI	Class II	1983-03-29
K830612	Chemo-Table	Fabrications Unltd.	FWZ	Class I	1983-03-29
K830610	Flat Suction Drain	Sil-Med Corp.	GBC	Class II	1983-03-29
K830574	Renatron Dialyzer Reprocessing Sys	Renal Systems, Inc.	LIF	Class II	1983-03-29
K830573	Pre Vue	Taut, Inc.	FOZ	Class II	1983-03-29
K830564	Feb Test	FUJIFILM Healthcare Americas Corporation	CFM	Class I	1983-03-29
K830545	Dispersive Electrode	C.R. Bard Inc	GEI	Class II	1983-03-29
K830509	Emergency Tracheostomy & Cricothyroido-	Frederic J. Toye, M.D.	BTO	Class II	1983-03-29
K830427	Arm Cushion	Maddak, Inc.	KIC	Class I	1983-03-29
K830386	Davol Surgical Suction Irrigation Instr	C.R. Bard Inc	FQH	Class II	1983-03-29
K830319	Auto Prep	Pm America, Inc.	JQW	Class I	1983-03-29
K830291	Wak Wearable Artificial Kidney	Wak-Utah	KOC	Class II	1983-03-29
K830278	Floret Gauze Packing	Ritmed, Inc.	EFQ	Unclassified	1983-03-29
K830276	Securet Drape & Instrument Retainer/incl	Ritmed, Inc.	GTC	Class I	1983-03-29
K830265	Floret Drain/tracheotomy Sponge	Ritmed, Inc.	EFQ	Unclassified	1983-03-29
K830194	Idas Infusion Set	Idas America, Ltd.	FPA	Class II	1983-03-29
K823843	Freeman Acetabular Cup	Depuy, Inc.	DXQ	Class II	1983-03-29
K823839	Ampco Kidney Dialysis Tray	Associated Medical Products Co.	KOC	Class II	1983-03-29