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 3345 of 3526

510(k) clearances, page 3345 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K801320	Sfx-90 Table/spotfilmer W/fluoricon L200	General Electric Co.	JAA	Class II	1980-07-21
K801317	Quadra Wheelchair, Quadra Chair, Etc.	Quadra Wheelchairs, Inc.	IQC	Class II	1980-07-21
K801305	Hippurate Disk	Remel Co.	JTC	Class I	1980-07-21
K801277	Gdc 934	Deringer-Ney, Inc.	EJS	Class II	1980-07-21
K801231	Eye-Vac	Coburn Optical Ind., Inc.	HKP	Class II	1980-07-21
K801198	Folate Radioassay Kit	Calbiochem-Behring Corp.	CGN	Class II	1980-07-21
K801163	Sunburst, Sun Systems or Bc2	Sun Ray Mfg., Inc.	LEJ	Class II	1980-07-21
K801095	The Sun Booth	Sun Booths, Ltd.	LEJ	Class II	1980-07-21
K801070	Sherwood Disposable Endometrial Samples	Sherwood Medical Industries	HHK	Class II	1980-07-21
K801061	Total Protein Test	Environmental Chemical Specialties	CEK	Class II	1980-07-21
K801039	Adaptaid Helical Coil Adapter 365-14	Intermedics, Inc.	DTD	Class II	1980-07-21
K800925	Verify S Prod. #34141	General Diagnostics	GGW	Class II	1980-07-21
K800850	High Stoy Small Parts Scanner #Sp-100B	Highstoy	DXK	Class II	1980-07-21
K800815	Enteral & Nasogastric Sol. Admin. Set	G.D. Searle and Co.	KNT	Class II	1980-07-21
K800805	Linear Array Scanner	Philips North America LLC	DXK	Class II	1980-07-21
K800653	Sinvision Linear Array Real Time	Kt Medical, Inc.	DXK	Class II	1980-07-21
K800596	Vita/trac 4-Function Vital Sign Monitor	Bib, Inc.	DXN	Class II	1980-07-21
K800553	Ultra Imager	Honeywell, Inc.	DXK	Class II	1980-07-21
K800496	Cycler W/5 or 10 Hr. Fill/dwell Timer	American Medical Products LLC	KPF	Class II	1980-07-21
K800405	A-V Mini Clinic	Instromedix, Inc.	DRT	Class II	1980-07-21
K801435	Organon Arterial Blood Sampler	Akzona, Inc.	CBT	Class I	1980-07-18
K801549	Model R11 Single Channel Chart Recorder	Medasonics, Inc.	DSF	Class I	1980-07-14
K801544	Porta-Fib Lpd	Narco Bio-Systems	LDD	Class II	1980-07-14
K801534	Lares Air Pressure Gauge	Lares Manufacturing Co., Inc.	EIA	Class I	1980-07-14
K801523	Model 379 Wxygen Concentrator	Stanley Aviation Corp.	CAW	Class II	1980-07-14
K801516	Pre-Dent System Modified	Pre-Dent System	KSS	Class I	1980-07-14
K801514	Timeter Produced Purritan Bennett O2 Adp	Timeter Instrument Corp.	BYX	Class I	1980-07-14
K801509	Hi-M-Test for Methadone Test #2	Technam, Inc.	DIW	Class II	1980-07-14
K801490	Digoxin Eia Kit	M.A. Bioproducts	LCS	Class II	1980-07-14
K801489	Ez on Safety Poncho	Skil-Care Corp.	KNO	Class I	1980-07-14
K801470	Micro Clip Sterilizing Case #65199	Edward Weck, Inc.	FSM	Class I	1980-07-14
K801457	Accu-Core Disposable Biopsy Needle	MEDLINE INDUSTRIES, LP - Northfield	GAA	Class I	1980-07-14
K801452	Orotracheal Intubation Endoscope	Olympus Corp.	CCW	Class I	1980-07-14
K801445	Skin Stapler Handle 523700/Cartridges	Edward Weck, Inc.	GAG	Class II	1980-07-14
K801444	Skin Staple Remover #523770	Edward Weck, Inc.	GDT	Class I	1980-07-14
K801443	P-S Suction Reservoir	Pudenz-Schulte Medical Research Corp.	GCY	Class I	1980-07-14
K801442	P-S Surgical Drain	Pudenz-Schulte Medical Research Corp.	GCY	Class I	1980-07-14
K801437	Dispensing Serological Pipet	Amt Corp.	JTC	Class I	1980-07-14
K801425	Rh Control	North American Biologicals, Inc.	KSF	Class II	1980-07-14
K801409	Gammadab B-Hcg Radioimmunoassay Kit	Travenol Laboratories, S.A.	JHI	Class II	1980-07-14
K801391	Disc 120 Transporter	Travenol Laboratories, S.A.	JZW	Class I	1980-07-14
K801386	Pre-Dent System or Pre-Dent II	Pre-Dent System	KSS	Class I	1980-07-14
K801378	Hipp Buffer(non-Barbital), P/n	Gelman Sciences, Inc.	JJN	Class I	1980-07-14
K801375	Shiley Cardiotomy Reservoir W/filter	Shiley, Inc.	DTP	Class II	1980-07-14
K801373	Beckman Model 42 Spectrophotometer	Beckman Instruments, Inc.	JJQ	Class I	1980-07-14
K801360	Cardiotomy Reservoir with Filter	Travenol Laboratories, S.A.	DTP	Class II	1980-07-14
K801350	Acuvac(tm) Suction Reservoir 400Cc and	Innovative Surgical Products, Inc.	GCY	Class I	1980-07-14
K801318	Helena Ultra Sensitive Cpk Reagent/dilue	Helena Laboratories, Corp.	JHX	Class II	1980-07-14
K801299	Cobas Ck-Nac Reagent	Roche Analytical Instruments, Inc.	CGS	Class II	1980-07-14
K801268	Hemoglobin Control Levels	Bioscientific	KHG	Class II	1980-07-14