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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3343 of 3526

510(k) clearances, page 3343 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K801572	Surg-Assist	Medmetric Corp.	FWZ	Class I	1980-08-04
K801555	Compact Model 360 Galvanic Epilator	Associated Electrolysis Group	KCW	Class I	1980-08-04
K801554	Sterile Cast Padding	Medi-Spec	HIX	Class I	1980-08-04
K801529	Kerr Core Composite	Sybron Corp.	EBF	Class II	1980-08-04
K801518	Span-Aid Bridging Pillow System	Span-America Medical Systems, Inc.	HKX	Class II	1980-08-04
K801453	Finger, Hand & Wrist Exerciser	Robert W. Slack	ION	Class I	1980-08-04
K801157	Weber-Mayo Wrist	Depuy, Inc.	KWM	Class II	1980-08-04
K800737	Debrisan (Dextranomer) Paste	Pharmaseal Laboratories	KOZ	Class I	1980-08-04
K801643	Triton	Chattanooga Group, Inc.	INW	Class I	1980-07-28
K801641	Ohio Disposable Clear Suction Instrument	Ohio Medical Products	DTS	Class II	1980-07-28
K801627	Cover, Limb	The Owenby Co.	IPM	Class I	1980-07-28
K801626	Arm Sling	The Owenby Co.	ILI	Class I	1980-07-28
K801625	Thermolator Heating Unit	Tru-Eze Mfg. Co., Inc.	IRQ	Class I	1980-07-28
K801606	Retreat	Omnitronics Research Corp.			1980-07-28
K801570	Shield Disp. Patients Poncho Gowns	American Convertors Div., American Pharmaseal	FYB	Class II	1980-07-28
K801569	Val-U-Wrap Csr Wrap	American Convertors Div., American Pharmaseal	FRG	Class II	1980-07-28
K801568	Shield Disposable Blood Pressure Cuff	American Convertors Div., American Pharmaseal	DXQ	Class II	1980-07-28
K801558	Enteric Feeding Tube W/segm. Flex. Wt.	Biosearch Medical Products, Inc.	KNT	Class II	1980-07-28
K801556	Rionet Hearing Aid Hb-66	Rion Acoustic Instruments, Inc.	ESD	Class I	1980-07-28
K801552	Mod. 9542 Flow-Thru Inject. Temp. Sensor	Edwards Laboratories	KRB	Class II	1980-07-28
K801532	Stockinette, Sterile Two Ply W/pull Tabs	The Owenby Co.	FQM	Class I	1980-07-28
K801530	Coreform Molds	Sybron Corp.	DZN	Class I	1980-07-28
K801522	Argyle Rigid Urine Measuring/coll. Dev.	Sherwood Medical Co.	KNX	Class II	1980-07-28
K801513	Tissue Processing System	Innovative Medical Systems, Inc.	IEO	Class I	1980-07-28
K801511	Naso-Gard Nasogastric Tube Holder	Howmedica Corp.	KNT	Class II	1980-07-28
K801506	Certified Blood Bank Saline	Nobel Scientific Industries, Inc.	JCE	Class I	1980-07-28
K801498	Entri Nasogastric Feeding Tube	Biosearch Medical Products, Inc.	KNT	Class II	1980-07-28
K801473	Cinoxacin 100 Mcg. Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1980-07-28
K801471	Super Banish Deodorant	Howmedica Corp.	EXB	Class I	1980-07-28
K801469	Bonn Micro Iris Hook (Non-Sterile) #7613	Edward Weck, Inc.	HNQ	Class I	1980-07-28
K801467	Dodick Lens Holding Forceps	Edward Weck, Inc.	HNR	Class I	1980-07-28
K801466	Leigh Measuring Scale #7725	Edward Weck, Inc.	HLN	Class I	1980-07-28
K801465	Gaskin Fragment Forceps(mfg. Non-Sterile	Edward Weck, Inc.	HNR	Class I	1980-07-28
K801462	Spor-O-Therm	Mdt Corp., Inc.	JTQ	Class I	1980-07-28
K801461	Therma-Shield	Olympic Medical Corp.	FMZ	Class II	1980-07-28
K801460	Pacific Hemostasis Thrombo-Screen Kaptt	Pacific Hemostasis	GGW	Class II	1980-07-28
K801458	Winter Head Dressing	Steridyne Corp.	FQM	Class I	1980-07-28
K801446	Pfizer Pz-CT Scanner	Pfizer Medical Systems, Inc.	JAK	Class II	1980-07-28
K801438	Centrifichem System Manager	Union Carbide Corp.	JQP	Class I	1980-07-28
K801429	Sunsation	Fashion, Inc.	LEJ	Class II	1980-07-28
K801427	Tissue-Tek III Mini-Rapid Processor	Miles Laboratories, Inc.	IEO	Class I	1980-07-28
K801426	Tissue-Tek III Microject Disp. Blade Sys	Miles Laboratories, Inc.	IDL	Class I	1980-07-28
K801421	Tube Holder	Devon Industries, Inc.	LDQ		1980-07-28
K801408	Cinescope III	Philips North America LLC	IZO	Class I	1980-07-28
K801407	Synerview Model 6545	Philips North America LLC	JAK	Class II	1980-07-28
K801406	Mark III Ultrasonic Scanning System	Advanced Technology Laboratories, Inc.	IYO	Class II	1980-07-28
K801389	Baro/trac II & Vita/trac, Vital Sign Mon	Bib, Inc.	DXN	Class II	1980-07-28
K801388	Oh-Harris	Johnson & Johnson Professionals, Inc.	KIH	Class I	1980-07-28
K801381	Fite Fixation Toy for Ocular Exam	Fite Engineering Corp.	HPL	Class I	1980-07-28
K801366	Disposable Temperature Probe Cover	Bib, Inc.	FLL	Class II	1980-07-28