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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2717 of 3530

510(k) clearances, page 2717 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882035	Heart-Chill Saline Slush Pad	Buckman Co., Inc.	DWJ	Class II	1988-07-28
K882034	Intra-Art(tm) Internal Mammary Infusion Catheter	Buckman Co., Inc.	DWF	Class II	1988-07-28
K882031	Vitalert 2000 Vital Signs Monitor	Draeger, Inc.	DXO	Class II	1988-07-28
K881968	Biodynamics Model Bi-400 Body Composition Analyzer	Biodynamics Corp.	DSB	Class II	1988-07-28
K881896	Kirschner Super-Fixation System	Kirschner Medical Corp.	JEC	Class II	1988-07-28
K881884	Harbor Central Venous Catheter	Harbor Medical Devices, Inc.	DQR	Class II	1988-07-28
K881878	Catheter Withdrawal Unit	Eris Medical Technology	KNY	Class II	1988-07-28
K881816	Abuscreen(r) Ontrak(tm) for Barbiturates	Roche Diagnostic Systems, Inc.	DKN	Class II	1988-07-28
K881249	Baggish, Hysteroscope	Bryan Corp.	HIH	Class II	1988-07-28
K881218	Gent-L-Kare Cleansing Enema Set	Geneva Laboratories, Inc.	FCE	Class I	1988-07-28
K881213	Gent-L-Kare Sterile Urinary Drainage Bag Center	Geneva Laboratories, Inc.	KNX	Class II	1988-07-28
K881155	Model Bps08 Blood Pressure Module	Fresenius USA, Inc.	DXN	Class II	1988-07-28
K880933	Amerlite Lh-30 Assay, Lan.0082/2082 240/144 Test	Amersham Corp.	CEP	Class I	1988-07-28
K880612	Cordis Pta Dilatation Catheters	Cordis US Corp.	LIT	Class II	1988-07-28
K880332	Medrad Open Ended Guidewire	Medrad, Inc.	DQX	Class II	1988-07-28
K875175	Modified Peripheral Dilatation Catheters	Schneider-Shilley (USA)	LIT	Class II	1988-07-28
K873452	Modified Model Ssd-650 System	GE Medical Systems Information Technologies, Inc.	IYO	Class II	1988-07-28
K882640	Tecnol Secure-All Pelvic Traction Belt	Tecnol New Jersey Wound Care, Inc.	KQZ	Class I	1988-07-27
K882036	Williams Acs Marker Needle	Buckman Co., Inc.	GDF	Class I	1988-07-27
K882025	Modified Extravakit	Extravakit, Inc.	FMF	Class II	1988-07-27
K881838	Modified Permagum Adhesive	Espe GmbH (US)	EBH	Class I	1988-07-27
K881153	Lifepak 9 Defibrillator and Cardiac Monitor	Physio Control, Inc.	LDD	Class II	1988-07-27
K882924	Medicam Mc-7 and Rp-7 Surgical Cameras	M.P. Video, Inc.	KQM	Class I	1988-07-26
K882109	Disposeable Menstrual Panty	Glamor Plus Co.	HHD	Class I	1988-07-26
K881992	Syrette	Oratec Corp.	EKJ	Class I	1988-07-26
K881885	Battery Packs (Other Than Cv)	Dowit Service Co., Inc.	FCP	Class I	1988-07-26
K881796	Umi Disposable Butterfly Style Puncture Needle	Universal Medical Instrument Corp.	DWS	Class I	1988-07-26
K875088	Xenon CT	Siemens Medical Solutions USA, Inc.	JAK	Class II	1988-07-26
K882660	General Surgical Table and Accessories	American Sterilizer Co.	FQO	Class I	1988-07-25
K882628	Endo C Brush	Milex Products, Inc.	HHT	Class II	1988-07-25
K882606	Euro-Med Endo-Curette	Buckman Co., Inc.	PCF	Class II	1988-07-25
K882601	E-Z-Em(r) Lufkin Biopsy Needles	E-Z-EM, Inc	GDM	Class I	1988-07-25
K882490	Hycel Quick-Lysing Hemoglobin Reagent	R & D Systems, Inc.	GIF	Class I	1988-07-25
K881985	Contra Angle Handpiece Attach. W/prophylaxis Cup	Denticator	EFB	Class I	1988-07-25
K881974	Proficient(tm) Prophylaxis Angle	Block Drug Company, Inc.	EFB	Class I	1988-07-25
K881787	Acs Hi-Torque Standard & Intermedi. Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1988-07-25
K881754	Ite Type Hearing Aid H.a.f. Model Elite	Brown Hearing Aid Centers	ESD	Class I	1988-07-25
K881703	3M Carpal Tunnel	3M Company	HRX	Class II	1988-07-25
K880783	Abbott Testpack Chlamydia	Abbott Medical	LJC	Class I	1988-07-25
K880775	Continuous Arterial/venous Hemofiltration Tray	Medsurg Industries, Inc.	LFK	Class II	1988-07-25
K880550	Burrows-Knudson Automated Lung Function Inter. Sys	Medimicro Systems, Inc.	BZM	Class II	1988-07-25
K874943	Sonar-Aid(r) Ultrasound Standoff Pad	Geistlich Pharma AG	ITX	Class II	1988-07-25
K882680	Alternate Blood Port Design for Addit. Memb. of Ca	Baxter Healthcare Corporation	FJI	Class II	1988-07-22
K882429	Model 255A Programmer III, W/software Revi. 4004	Tpl-Cordis, Inc.	KRG	Class III	1988-07-22
K882308	Cr-39 Plastic Lenses for Eyeglasses	Automated Lens System	HQG	Class I	1988-07-22
K882290	Card Guard, Model Cg-2000	Card Guard Scientific Survival, Ltd.	DXH	Class II	1988-07-22
K882174	Modified Model 5455 Disposable Surgical Cable	Medtronic Andover Medical, Inc.	DSA	Class II	1988-07-22
K881904	Change to Cathode Powder Specification	Telectronics and Cordis Pacing Systems	DXY	Class III	1988-07-22
K882659	Augustine Intubation Guide(tm)	Augustine Medical, Inc.	CCW	Class I	1988-07-21
K882549	Acuson Transrectal Needle Guide for Intra. Appli.	Acuson Corp.	FCG	Class II	1988-07-21