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 3356 of 3526

510(k) clearances, page 3356 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800750	Stomahesive Sterile Wafer	Squibb & Sons, Inc.	EXB	Class I	1980-05-08
K800734	Rapid Fermentation Agar (Rfa)	Remel Co.	JSE	Class I	1980-05-08
K800726	Eyewi Ankors	Eyevi & Co.	KMK	Class I	1980-05-08
K800721	General Utility Surg. Scissors #460180-	Edward Weck, Inc.	HRR	Class I	1980-05-08
K800719	Enzymatic Urea Nitrogen Reagent Set Revi	Macomb Chemical Co.	CDQ	Class II	1980-05-08
K800711	Volumetric Pump Cassette W/attached Set	Travenol Laboratories, S.A.	FPA	Class II	1980-05-08
K800704	C-Dak Tm 2800 Artificial Kidney	Cordis US Corp.	FJI	Class II	1980-05-08
K800702	Ta-641 Tinnitus Instrument	Audiotrone	KLW	Class II	1980-05-08
K800699	Flo Tem (Fluid Warner)	Chroma Products, Inc.	KZL	Class II	1980-05-08
K800668	Cannula, W/sharp Obturator & Veress Need	Karl Storz Endoscopy-America, Inc.	HET	Class II	1980-05-08
K800666	Quik-Temp	Liquid Crystal Products, Inc.	KPP	Class II	1980-05-08
K800649	Enzymatic Triglycerides Reafent for Smac	Reagents Applications, Inc.	CDT	Class I	1980-05-08
K800638	Plasma Products Co. Non-Vented Intra/set	Plasma Products Co.	FPA	Class II	1980-05-08
K800637	Plasma Products Co., Intra/admin/set-	Plasma Products Co.	FPA	Class II	1980-05-08
K800527	Cliniguard	Clinipad Corp.	KMF	Class I	1980-05-08
K800086	Rms 111F Respiratory Monitoring System	Revvity Health Sciences, Inc.	BZK	Class II	1980-05-08
K800067	Vita Lamp, Model 0350	Tensor Industries, Inc.	KZF	Class I	1980-05-08
K792089	The Howmedica Kinematic Knee System	Howmedica Corp.	JWH	Class II	1980-05-06
K801004	Flow Med 160	D.R.O. Medical, Inc.	FPA	Class II	1980-05-02
K800994	Austry Alloy(dental Bake-on Alloy)	Howmedica Corp.	EJS	Class II	1980-05-02
K800958	Personal Sitz Bath Kit	The Healthcare Group Laboratories, Inc.	KTC	Class I	1980-05-02
K800917	Tru-Cold Therapy Pak	Tru-Eze Mfg. Co., Inc.	IME	Class I	1980-05-02
K800898	Silastic Bone Plug H.p.(cement Restrict)	Dow Corning Corp. Healthcare Industries Materials	JDS	Class II	1980-05-02
K800894	Dupuy Cement Restrictor Trials & Instr.	Depuy, Inc.	JDI	Class II	1980-05-02
K800888	Tricyclic Antidepressants I Tx Control	Utak Laboratories Inc	DIF	Class I	1980-05-02
K800861	Snyder Hemovac Chest Drainage Solution	Snyder Laboratories, Inc.	KDQ	Class II	1980-05-02
K800852	Hemespec Check Set	Helena Laboratories, Corp.	KRZ	Class II	1980-05-02
K800817	Shield Disp. Reinforced Drape Sheets	American Convertors Div., American Pharmaseal	KKX	Class II	1980-05-02
K800745	Cellibiose-Arginine-Lysine Agar (Cal)	Remel Co.	JSI	Class I	1980-05-02
K800716	Orthotic Leg Gait Corrector Device	Ipos Luneburg	ITO	Class I	1980-05-02
K800715	Ohc Dynamic Club Foot Brace	Ipos Luneburg	IQI	Class I	1980-05-02
K800697	Sunhouse Uvb Ultraviolet Light Tanning	Progressive Productions, Ltd.			1980-05-02
K800695	Bvn	Donald J. Mangus, M.D.	ITG	Class I	1980-05-02
K800632	Model 118 Pulse Megason	Birtcher Corp.	IMI	Class II	1980-05-02
K800617	Hyfrecator, #733	Birtcher Corp.	GEI	Class II	1980-05-02
K800564	General Electric Radview Mark I System	General Electric Co.	KPR	Class II	1980-05-02
K800484	Mod. 3127 Neuromuscular Stimulator	Medtronic, Inc.	IPF	Class II	1980-05-02
K800433	Helena Colocheck	Helena Laboratories, Corp.	KHE	Class II	1980-05-02
K800387	Pulse Generators Models 657 & 677	Siemens Elema AB	DXY	Class III	1980-05-02
K800336	Gambro Lundia Fiber	Gambro, Inc.	FJI	Class II	1980-05-02
K800279	Medspec Rubber Bands	Medspec Corp.			1980-05-02
K800278	Medspec Safety Pins	Medspec Corp.	KKX	Class II	1980-05-02
K800134	Hope Model 126, Auto/proces., Den. Flm	Hope Industries, Inc.	IWZ	Class I	1980-05-02
K800101	4200 Me Echoencephalograph	Kt Medical, Inc.	IYO	Class II	1980-05-02
K800910	Gal-Put Controls, Normal&deficient	Sigma Chemical Co.	JIX	Class II	1980-04-29
K800900	Premier Triple Tray	Premier Dental Products Co	EHY	Class I	1980-04-29
K800889	Tricyclic Antidepressant II Tx Control	Utak Laboratories Inc	DIF	Class I	1980-04-29
K800887	Hypnotics Plus Salicylate Tx Control	Utak Laboratories Inc	DIF	Class I	1980-04-29
K800886	Hypnotics Plus Acetaminophen Tx Control	Utak Laboratories Inc	DIF	Class I	1980-04-29
K800885	Barbiturates Toxicology Control	Utak Laboratories Inc	DIF	Class I	1980-04-29