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 1854 of 3531

510(k) clearances, page 1854 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K971650	Rhythmstat Xl	Data Critical Corp.	DXH	Class II	1997-12-04
K971362	Personal Infusor	Science Incorporated	MEB	Class II	1997-12-04
K970773	Powder-Free Exam Gloves	Pt. Sarana Indoprotex	LYY	Class I	1997-12-04
K961289	Vapophene	Germiphene Corp.	MED	Class II	1997-12-04
K973798	S-357 Video Imaging System	Sopro	FET	Class II	1997-12-03
K973784	Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests	Biosite Incorporated	DKZ	Class II	1997-12-03
K973742	Sendx 100 Ph, Blood Gas and Electrolyte Analysis System	Sendx Medical, Inc.	CGZ	Class II	1997-12-03
K973437	Hewlett-Packard Models M1001b ECG M1002b Ecg/respiration Plug-in Modules	Hewlett-Packard Co.	DPS	Class II	1997-12-03
K973340	Tweezer-Type Epilator	Mobit, Inc.	KCX	Class I	1997-12-03
K973324	Starlight Pulsed Diode Array Laser System	Star Medical Technologies, Inc.	GEX	Class II	1997-12-03
K973611	Spectrascience Reusable Biopsy Forceps	Spectrascience, Inc.	FCL	Class I	1997-12-02
K973484	Chin Distractor	Howmedica Corp.	JEY	Class II	1997-12-02
K973463	Olicon Imaging Systems, Inc. Archive Systems, Nt Archive, 02Archive, Archive	O Tech, Inc.	LMB	Class I	1997-12-02
K973415	Curvilinear Suture Placement System	Laurus Medical Corp.	GCJ	Class II	1997-12-02
K973370	Aquaplast Palatal Stent	Anholt Technologies Inc.	EMA	Class II	1997-12-02
K973353	Bonding Base	Straumann USA, LLC	DZE	Class II	1997-12-02
K973332	Alcon Multi-Purpose Disinfecting Solution Id 90746	Alcon Laboratories	LPN	Class II	1997-12-02
K973325	Bact/alert Fan Culture Bottles	bioMerieux, Inc.	MDB	Class I	1997-12-02
K973315	Therapax Dxt 300 Model HF-300	Pantak, Inc.	JAD	Class II	1997-12-02
K973304	Mvm 3.3 Mm Microendoscope	Karl Storz Endoscopy-America, Inc.	HET	Class II	1997-12-02
K973302	Foundation Porous Hip Stem	Encore Orthopedics, Inc.	LPH	Class II	1997-12-02
K972230	Quickie P90 Series	Quickie Designs, Inc.	ITI	Class II	1997-12-02
K971735	Accudexa Bone Densitometer	Schick Technologies, Inc.	KGI	Class II	1997-12-02
K971441	Quanta Lite Toxoplasma Igg	Inova Diagnostics, Inc.	LGD	Class II	1997-12-02
K971440	Fukuda Denshi Model Fcp-2155 Multi Channel, Interpretive Electrocardiograph	Fukuda Denshi USA, Inc.	LOS		1997-12-02
K971243	Ohmeda Infant Resuscitation System	GE Healthcare	BTM	Class II	1997-12-02
K965016	ISO-Gard Filter Angled(18212)/iso-Gard Filter Straight(19212)	Gibeck, Inc.	CAH	Class II	1997-12-02
K952267	Criterion, Criterion i.v., Modified	Nova-Ventrx	BZE	Class II	1997-12-02
K974179	Non-Prescription Sunglasses	Taipan Optical Company, Ltd.	HQY	Class I	1997-12-01
K973928	Beckman Urine Protein Calibrator (Ucal)	Beckman Instruments, Inc.	JIX	Class II	1997-12-01
K973855	It Hydrocolloid with Zinc	Innovative Technologies, Ltd.	FRO	Unclassified	1997-12-01
K973841	Quickvue One-Step Hcg-Combo	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	1997-12-01
K973657	Arglaes-Ab Antimicrobial Barrier Island Dressing	Maersk Medical A/S	MGP	Unclassified	1997-12-01
K973496	The Auto Suture* Mibb** System	United States Surgical, A Division of Tyco Healthc	KNW	Class II	1997-12-01
K973495	Glenroe Glow in Dark Elastomeric Ligatures	Glenroe, LLC	ECI	Class I	1997-12-01
K973479	Cefmetazole Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1997-12-01
K973429	Bioderm Foam Wound Dressing	Bioderm, Inc.	KMF	Class I	1997-12-01
K973323	Acl Clip-in	Innovasive Devices, Inc.	MBI	Class II	1997-12-01
K973313	Innovasive Devices Y-Knot Suture Clip	Innovasive Devices, Inc.	OCW	Class II	1997-12-01
K972457	Monocol/lex-Im Test	Immunostics, Inc.	KTN	Class II	1997-12-01
K972112	Intraducer Port Sc Catalog#31275,31035,30915, and 31450	Taut, Inc.	GBW	Class I	1997-12-01
K972064	Microcon 800Muv, Microcon 400Muv, Microcon Exc-Buv	Biological Controls, Inc.	FRA	Class II	1997-12-01
K971335	Quanta Lite Cmv Igg Elisa	Inova Diagnostics, Inc.	LFZ	Class II	1997-12-01
K971205	Tri Test Reagent Cd4 Fit C/cd8 Pe/cd3 Percp with Trucount Absolute Count Tubes	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1997-12-01
K964703	The Ca 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)	Bayer Corp.	MOI	Class II	1997-12-01
K964622	Medi-Dx 7000	Neuro-Diagnostic Assoc.	LLN	Class I	1997-12-01
K974108	Serum Hcg Control Set (Negative, Low Positive and High Positive)	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	1997-11-26
K973858	Cards Q.s. Hcg Serum/urine;concise Performance Plus Hcg-Combo	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	1997-11-26
K973780	Personal Lubricating Liquid	Qualis, Inc.	HIS	Class II	1997-11-26
K973671	Endocervical Block Needle	A & A Medical, Inc.	HEE	Class II	1997-11-26