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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2919 of 3529

510(k) clearances, page 2919 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K855074	Filtered Vacuum Safety Trap Bottle	Boehringer Laboratories, LLC	KDQ	Class II	1986-03-13
K854755	Renamel Esthetic Restorative System	Cosmedent, Inc.	EBF	Class II	1986-03-13
K854415	Endometrial Pipelle	Unimar, Inc.	HHK	Class II	1986-03-13
K854198	Pe-3000 Pulse Rate Monitor	Quantum Life Systems, Inc.	DRT	Class II	1986-03-13
K854168	Travenol Disposable Dental Scalers/curettes	Travenol Laboratories, S.A.	ELA	Class I	1986-03-13
K853147	Scano 731B & 731C Ultrasound Soft Tis Dept Meas Sy	Scano, Inc.	IYO	Class II	1986-03-13
K852574	Welch Allyn Model 40000 Sphyg W/ 40030-35 Blad & C	Welch Allyn Inc	DXN	Class II	1986-03-13
K860795	Spottest Calcofluor White Reagent	Difco Laboratories, Inc.	LED	Class I	1986-03-12
K860788	Ham's F-12 W/glutamine & Nahco3	Tissue Culture Innovations	KIT	Class I	1986-03-12
K860787	Dulbecco's Mem	Tissue Culture Innovations	KIT	Class I	1986-03-12
K860786	Rpmi 1640 Hepes	Tissue Culture Innovations	KIT	Class I	1986-03-12
K860785	Ham's F-12 W/nahco3	Tissue Culture Innovations	KIT	Class I	1986-03-12
K860784	Dulbecco's Phosphate Buffered Saline W/calcl2	Tissue Culture Innovations	KIP	Class I	1986-03-12
K860783	Micro Carrier	Tissue Culture Innovations	KIT	Class I	1986-03-12
K860695	Gibco Mycotect Kit (Catalog No. 189-5672)	Gibco Laboratories Life Technologies, Inc.	KIW	Class I	1986-03-12
K860441	Entrokit with Maglinte Catheter	Lafayette Pharmacal, Inc.	KGC	Class II	1986-03-12
K860244	A & M 150 Pp (Hearing Aid)	Electone, Inc.	ESD	Class I	1986-03-12
K860191	Pa Presidential II - Hearing Aid	Electone, Inc.	ESD	Class I	1986-03-12
K860190	A & M Discreet - Hearing Aid	Electone, Inc.	ESD	Class I	1986-03-12
K860058	Denpax	Nissho Iwai American Corp.	EBR	Class I	1986-03-12
K860008	Am 31, Hearing Aid	Electone, Inc.	ESD	Class I	1986-03-12
K860007	Am 12, Hearing Aid	Electone, Inc.	ESD	Class I	1986-03-12
K855240	Behind the Ear Hearing Aids Model	Bernafon LLC	ESD	Class I	1986-03-12
K855124	Convex Probe, Pve-382M	Toshiba Medical Systems	IYO	Class II	1986-03-12
K855064	Swank Blood Transfusion Micro-Filter W/straight Se	Cobe Laboratories, Inc.	CAK	Class II	1986-03-12
K855044	Perinatal Computer Sys Model 100A & 100B	Peritronics Research and Development, Inc.	HGM	Class II	1986-03-12
K854938	Coascreener/diascreenerblood Plasma Timing Inst.	Diatech, Inc.	JPA	Class II	1986-03-12
K854700	Ez-on Tubing Conditioner (Lubricant)	Almore Intl., Inc.			1986-03-12
K854645	Gold Air, Gold Light	Alpine Dental Equipment Co.	EFB	Class I	1986-03-12
K854555	Gl590 Diagnostic Ultrasound Equipment	Gl Ultrasound, Ltd.	IYO	Class II	1986-03-12
K854467	S.t.p.b Soft Tissues Protectives Blades	Nortex USA, Inc.	EEJ	Class I	1986-03-12
K854414	Dumon/harrell	Bryan Corp.	EOQ	Class II	1986-03-12
K854166	Hematology Calibrator Control	Interscience Diagnostics, Inc.	KRZ	Class II	1986-03-12
K854112	Flexible Grasping Forceps	Hood Laboratories	EWL	Class II	1986-03-12
K853856	External Uterine Contraction Monitor-Tokodynamomet	Aequitron Medical, Inc.	HFM	Class II	1986-03-12
K853726	Laryngeal	Hood Laboratories	FWN	Class II	1986-03-12
K853115	Sonolayer S, Ssh-60A/sds-60A	Toshiba Medical Systems	DXK	Class II	1986-03-12
K852788	Rubalex	Orion Corp.	LQN	Class II	1986-03-12
K852168	Electronic Communication Sys Accessory for Gravity	Y	FRN	Class II	1986-03-12
K860707	Ofpbl	Remel Inc	JSI	Class I	1986-03-11
K860599	Ethox Lavage Tube	Ethox Corp.	KDH	Class II	1986-03-11
K860565	Differentiation Disks Kanamycin 1000 Mcg	Difco Laboratories, Inc.	JTO	Class I	1986-03-11
K860564	Differentiation Disks Erythromycin 60 Mcg	Difco Laboratories, Inc.	JTO	Class I	1986-03-11
K860563	Differentiation Disks Vancomycin 5 Mcg	Difco Laboratories, Inc.	JTO	Class I	1986-03-11
K860562	Differentiation Disks Colistin 10 Mcg	Difco Laboratories, Inc.	JTO	Class I	1986-03-11
K860561	Differentiation Disks Penicillin G 2 Units	Difco Laboratories, Inc.	JTO	Class I	1986-03-11
K860560	Differentiation Disks Rifampin 15 Mcg	Difco Laboratories, Inc.	JTO	Class I	1986-03-11
K860517	Mentor Corporal Dilators	Mentor	FAE	Class II	1986-03-11
K860484	Curity & Kenguard Silicone Coated Foley Catheter	The Kendal Co.	KOD	Class II	1986-03-11
K860369	Api Uniscept Micro-Mic Ceftriaxone/uniscept Mic	Analytical Products, Inc.	JWY	Class II	1986-03-11