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 2040 of 3531

510(k) clearances, page 2040 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K954251	5F Envoy Guiding Catheter (Modification)	Cordis Neurovascular, Inc.	DQY	Class II	1995-10-23
K954217	Arthroplast & Arthro-Cutter	Future Medical Systems, Inc.	HRX	Class II	1995-10-23
K954212	Contamination Containment Drape	Engineering Controls for Medicine	KKX	Class II	1995-10-23
K954193	Surgical Dynamics 30K Working Channel Scope & Instrument Set	Surgical Dynamics Ltd	HRX	Class II	1995-10-23
K954187	Triglycerides Reagent	Schiapparelli Biosystems, Inc.	JGY	Class I	1995-10-23
K954178	Osom Pregnancy Test	Wyntek Diagnostics, Inc.	LCX	Class II	1995-10-23
K954024	Chemstrip Criterion Urine Analyzer	Boehringer Mannheim Corp.	KQO	Class I	1995-10-23
K953992	Lumitrol Controller, Lumitrol Hand-Controlled Electrosurgical Pencil with Blade Electrode	Lmi Lightwave Medical Industries, Ltd.	GEI	Class II	1995-10-23
K953664	Vitalock Spiked Acetabular Shell	Howmedica Corp.	LPH	Class II	1995-10-23
K953377	Distention Balloon	Origin Medsystems, Inc.	GCJ	Class II	1995-10-23
K953248	Iris Bilateral Tmj	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1995-10-23
K953032	Lunar Dpx Densitometer	Lunar Corp.	KGI	Class II	1995-10-23
K952937	Niomed Non-Skid Shoe Covers	Amerasia Corp.	FXP	Class I	1995-10-23
K952897	Niomed Shoe Covers	Amerasia Corp.	FXP	Class I	1995-10-23
K952482	Ksea Reverse Video	Karl Storz Endoscopy-America, Inc.	FET	Class II	1995-10-23
K954680	Access Prolactin Assay (Modification)	Bio-Rad Laboratories Inc.	CFT	Class I	1995-10-20
K954257	Quickvue in-Line One Step Strep a Test (Modification)	Ortho-Clinical Diagnostics, Inc.	GTZ	Class I	1995-10-20
K954194	Disposable Hme/filter	Engstrom Medical	BYD	Class I	1995-10-20
K953903	Laparoscopic Trocar Obturator, 5Mm, 10/11Mm, 10/12Mm	Core Dynamics, Inc.	GCJ	Class II	1995-10-20
K953772	Breathe Right Nasal Strip	Cns, Inc.	LWF	Class I	1995-10-20
K953638	O.b. Applicator Tampons	Personal Products Co.	HIL	Class II	1995-10-20
K953490	Trilogy Acetabular Shell & Liners 36Mm	Zimmer GmbH	LPH	Class II	1995-10-20
K953472	Nellcor Symphony N-3100 Blood Pressure Monitor	Nellcor, Inc.	DXN	Class II	1995-10-20
K953437	Olympus Anti-Sterptolysin O Immunoturbidimetric Reagent	OLYMPUS Corporation of the Americas	GTQ	Class I	1995-10-20
K953264	Questus Polyester Suture Soft Tissue Anchor System	Wrightmedicaltechnologyinc	MBI	Class II	1995-10-20
K952178	Ph-Detect Test	Diagnostic Reagents, Inc.	JQY	Class I	1995-10-20
K951820	Thromboplastin-Li Reagent	Helena Laboratories, Corp.	GJS	Class II	1995-10-20
K951542	Directigen 1-2-3 Group a Strep Test	BD Becton Dickinson Vacutainer Systems Preanalytic	GTZ	Class I	1995-10-20
K951105	Karl Storz Pressure Cuff for Use with the Ksea Hydromat Pump	Karl Storz Endoscopy-America, Inc.	HET	Class II	1995-10-20
K946335	Opticlone(tm Cd3 Fitc/cd19 Pe Monoclonal Antibodies	IMMUNOTECH s.r.o.	GKZ	Class II	1995-10-20
K945857	Protein C Deficient Plasma	George King Bio-Medical, Inc.	GJT	Class II	1995-10-20
K945677	Il682, Co-Oximeter	Instrumentation Laboratory Co.	GKR	Class II	1995-10-20
K944689	Zirconia Ceramic Femoral Head	Wrightmedicaltechnologyinc	LZO	Class II	1995-10-20
K934866	Hys-Surgimat	Novanta Medical GmbH	HIG	Class II	1995-10-20
K954643	Try-in Gel	Sybron Dental Specialties, Inc.	EMA	Class II	1995-10-19
K954561	Xenon Noppva	Karl Storz Endoscopy-America, Inc.	GCT	Class II	1995-10-19
K954374	American Dental Products Orthodontic Adhesive, Two Paste Bonding System	American Dental Products, Inc.	DYH	Class II	1995-10-19
K954373	American Dental Products Paste-Primer Adhesive Orthodontic Bonding System W/fluoride	American Dental Products, Inc.	DYH	Class II	1995-10-19
K954299	Buhlmann Angiostensin II Ria	Buhlmann Laboratories AG	CIB	Class II	1995-10-19
K954189	Easi-Jector Control System	North, Inc.	FMF	Class II	1995-10-19
K953986	Powderfree Latex Glove	Steriltx	LYY	Class I	1995-10-19
K953749	Medi-Oxide Sterilzation Pouch from Medi-Plus	Curwood, Inc.	KCT	Class II	1995-10-19
K953732	Teca Premiere	Medelec, Ltd.	GWJ	Class II	1995-10-19
K953572	Elx800uv	Bio-Tek Instruments, Inc.	JJQ	Class I	1995-10-19
K953415	6200 Vital Signs Monitor	Bci Intl., Inc.	DPS	Class II	1995-10-19
K952628	Royal Shield Non-Sterile Powder-Free Rubber Dams	Elastomade Accessories Sdn Bhd	EIE	Class I	1995-10-19
K952474	Eagle 3000 Patient Monitor	Marquette Electronics, Inc.	DRT	Class II	1995-10-19
K952117	Epilator	Burke Neutech, Inc.	KCX	Class I	1995-10-19
K951627	Infinitech High Intensity Xenon Light Source System	Infinitech, Inc.	MPA	Class II	1995-10-19
K951496	Cell-Dyn 3500 Multi-Parameter Automated Hematology Analyzer	Abbott Medical	GKZ	Class II	1995-10-19