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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2372 of 3531

510(k) clearances, page 2372 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920970	Bactidrop Koh (10%)	Remel Inc	JTS	Class I	1992-06-09
K920207	Hermle Z230h	Labnet Intl., Inc.	GKG	Class II	1992-06-09
K920143	Tb Susceptibility Quads I and II	Remel Inc	MJD	Class II	1992-06-09
K920098	Access Qd Head Coil	Toshiba America Mri, Inc.	LNH	Class II	1992-06-09
K915723	.10' Hi-Torque Floppy, Inter. & Stand. Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1992-06-09
K914327	Seroelisa(tm) Chlamydia Iga Test Kit	Savyon Diagnostics Ltd.	LJC	Class I	1992-06-09
K914194	Scimed(r) Controlwire(tm) Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1992-06-09
K910830	Invalift	American Invalift Corp.	FRZ	Class II	1992-06-09
K910447	Dura Mater	Lifelink Foundation Tissue Bank	LEM	Class II	1992-06-09
K921146	Sharplan CO2 Surg. Laser, Mo. 1039 Surgicenter 40	Sharplan Lasers, Inc.	GEX	Class II	1992-06-08
K921131	Cks Oscillating Saw Blade	Techmedica, Inc.	HWE	Class I	1992-06-08
K920231	Omnifit M-Ha Hip Stem Series	Stryker Corp.	KWL	Class II	1992-06-08
K920193	Omniflex M-Ha Hip Stem Series	Stryker Corp.	KWL	Class II	1992-06-08
K915831	Thermal Probe Cover	Vermont Medical, Inc.	FMT	Class II	1992-06-08
K920659	Davol Endo-Flo Laser Probe and Accessories	Davol, Inc.	GEX	Class II	1992-06-05
K920062	Candela Pltl-1 Laser System: Pigmented Lesion Las.	Candela Corporation	GEX	Class II	1992-06-05
K914784	Papillion Proctoscope	Oldelft Corp. of America	KQA	Class II	1992-06-05
K914698	Setup Computer with Software V-1261,62 and 63	K.S., Inc.	IYE	Class II	1992-06-05
K913267	R-Group Intl. One Wall Puncture Needle	R-Group Intl.	DRC	Class II	1992-06-05
K922371	Spinal Positioning Frame	Rhino Mfg.	FQO	Class I	1992-06-04
K922109	King Diagnostics Alt (Gpt) Reagent	King Diagnostics, Inc.	CKA	Class I	1992-06-04
K921703	Continu-Flo(r) Solution Set	Baxter Healthcare Corporation	FPA	Class II	1992-06-04
K921402	Surgical Instrument, Disposable	Macro Medical, Inc.	LXH	Class I	1992-06-04
K921250	Synelisa Cardiolipin Antibodies	Elias U.S.A., Inc.	MID	Class II	1992-06-04
K921038	Eclipse 2100	Cardiogenes	GEX	Class II	1992-06-04
K920986	Snowden-Pencer High Flow Insufflator, Sp/88-9700	Snowden-Pencer	HIF	Class II	1992-06-04
K920895	Dade(r) Prothrombin Fragment F1.2 Elisa	Baxter Diagnostics, Inc.	MIF	Class II	1992-06-04
K920788	Blood Administration Set	Douglas Medical Products, Inc	BRZ	Class II	1992-06-04
K920597	Handi-Lase CO2 Surgical Laser Instrument	Sorenson Laboratories, Inc.	GEX	Class II	1992-06-04
K920318	Cedia Ferritin Assay	Microgenics Corporation	JMG	Class II	1992-06-04
K915895	Stealth Dilation Catheter System (Modified)	Target Therapeutics	LIT	Class II	1992-06-04
K915204	Multi Use Laparoscopy Electrosurgical Instrument	Conmedcorp	GEI	Class II	1992-06-04
K915051	Modification Model 7201 Insufflator	Northgate Technologies Inc.	HIF	Class II	1992-06-04
K914963	Smith & Nephew Dyonics Tmj Arthroscopy Inflow Set	Smith & Nephew Dyonics, Inc.	HRX	Class II	1992-06-04
K912462	Q-Ms Neuromuscular Stimulator	Quantitative Medicine, Inc.	IPF	Class II	1992-06-04
K922203	Ipt Capsule Mixer	Ipt Technologies, Inc.	EFD	Class I	1992-06-03
K921999	Interjet(tm) Gingival Care Instrument	Bausch & Lomb Incorporated	EFS	Class I	1992-06-03
K921645	Amsen Spine Impactor Instruments	Advanced Med/Surg, Inc.	LXH	Class I	1992-06-03
K921644	Amsen Hockey Stick Chisel	Advanced Med/Surg, Inc.	LXH	Class I	1992-06-03
K921643	Amsen Posterior Disc Evacuator	Advanced Med/Surg, Inc.	LXH	Class I	1992-06-03
K921642	Amsen Double-Ended Foraminal Probe	Advanced Med/Surg, Inc.	LXH	Class I	1992-06-03
K921323	Cervical Passive Motion	Rehabilitative Resources, Inc.	BXB	Class I	1992-06-03
K921135	Iolab Power i.v. Pole	Site Microsurgical Systems, Inc.	HQC	Class II	1992-06-03
K920998	Gore Tunneler, Modification	W. L. Gore & Associates, Inc.	DYB	Class II	1992-06-03
K920779	Fast-Cath Hemostasis Introducer	Daig Corp.	DYB	Class II	1992-06-03
K915625	Introducer Catheter	Interventional Therapeutics Corp.	DYB	Class II	1992-06-03
K915375	Odontit Osseointegrated Implants System	Odontit Systeme	DZE	Class II	1992-06-03
K915063	Ivac Pc Anifuser	Y	MEA	Class II	1992-06-03
K914299	Cardiac Catherization Kit	Abbott Medical	DQO	Class II	1992-06-03
K921633	Ors-2000 Series	Mnlase, Inc.	LHC	Class I	1992-06-02