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 2157 of 3531

510(k) clearances, page 2157 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941715	Ultathin Flexible Endoscope	Technology Marketing Group	LYK	Class II	1994-10-04
K941319	The Wuscope System	Achi Corp.	CCW	Class I	1994-10-04
K940913	Spine-Tech Laparoscopic Instrumentation System	Spine-Tech, Inc.	HRX	Class II	1994-10-04
K936245	Multi Analyte Linearity Set	Teco Diagnostics	JJY	Class I	1994-10-04
K934132	Porous Media Dbf23 Disposable Respiratory Filter	Pentair Filtration Solutions	CAH	Class II	1994-10-04
K932059	Needle Electrodes and Disposable Scalp Electrode	Dantec Medical, Inc.	IKT	Class II	1994-10-04
K926008	Pinnacle 3	Philips North America LLC	IYE	Class II	1994-10-04
K944722	Precision Uv(tm) (Vasurfilcon a)	Pilkington Barnes-Hind, Ltd.	LPL	Class II	1994-10-03
K944467	Aesculap Manual Laparoscopic Instruments	Aesculap Inc	GCJ	Class II	1994-10-03
K944375	N/t Rheumatology Control Sl/1, Sl/2	Behring Diagnostics, Inc.	DCK	Class II	1994-10-03
K944370	O-R-Ez Tip Cleaner	O-R-Ez, Inc.	GEI	Class II	1994-10-03
K944328	Tonka Boys Sunglasses	Hasbro Industries, Inc.	HQY	Class I	1994-10-03
K944288	Hemagen C-Reactive Protein Kit (Eia Method)	Hemagen Diagnostics, Inc.	DCK	Class II	1994-10-03
K944281	Sunglasses	Sun Glory Optic CO, Ltd.	HQY	Class I	1994-10-03
K944157	Disposable, Preformed Face Mask	Meridian Medical Systems, LLC	BSJ	Class I	1994-10-03
K944044	Chiba Style Biopsy Needle	Kormed, Inc.	LRO	Class II	1994-10-03
K943997	Behring Nephelometer II	Behring Diagnostics, Inc.	DEW	Class II	1994-10-03
K943636	Curaderm Alginate Hydrocolloid	Kendall Healthcare Products Co. Div.Of Tyco Health	KMF	Class I	1994-10-03
K943424	Cush Island Dressing	Cush Medical Products	MGP	Unclassified	1994-10-03
K942924	Msv-2000 Video Imaging System	Del Medical Systems Corp.	GCJ	Class II	1994-10-03
K942011	Sunglasses	Shanghai Gopher Arts & Crafts Co., Ltd.	HQY	Class I	1994-10-03
K941788	Band-Aid Brand Adhesive Bandages, Sport Strip	Johnson & Johnson Consumer Products, Inc.	KGX	Class I	1994-10-03
K941641	Disposable Emergency Obstetrical Kit	Gam Industries, Inc.	KNA	Class II	1994-10-03
K941434	K-Wires and Steinmann Pins	Omega Surgical Instruments, Inc.	HTY	Class II	1994-10-03
K941214	Lifeshield Extension Set	Abbott Mfg., Inc.	FPK	Class II	1994-10-03
K941146	Dupont Aca Plus Thyroid Stimulating Hormone System	Dupont Medical Products	JLW	Class II	1994-10-03
K941048	True/lok Monolateral/bilateral Fixator	Applied Osteo Systems, Inc.	LXT	Class II	1994-10-03
K940536	Band-Aid(tm) Brand Adhesive Bandage	Johnson & Johnson Consumer Products, Inc.	KGX	Class I	1994-10-03
K940396	Wallstent Esophageal Prosthesis (Double)	Boston Scientific Corporation	ESW	Class II	1994-10-03
K940249	Certiburn Burn/trauma Face Dressing /Towel Dressing	Certified Safety Mfg Inc	LRR	Not classified	1994-10-03
K936037	S-Rom Noiles Cruciate Retaining Knee	Joint Medical Products Corp.	JWH	Class II	1994-10-03
K935509	Hydrotrack	Ferno Ille	BXB	Class I	1994-10-03
K935049	Elegance Neonatal Tsh Elisa	Bioclone Australia Pty, Ltd.	JLW	Class II	1994-10-03
K933964	The Cradle	The Primal Energy Research Foundation	IKZ	Class II	1994-10-03
K933916	Ausonics Opus 2 Realtime Ultrasound Scanner	Ausonics Pty, Ltd.	IYN	Class II	1994-10-03
K932204	E-Z Therm 3 Second Thermometer	North American Technical Services Corp.	FLL	Class II	1994-10-03
K925999	Swemed Needle Guide	Swemed Lab Intl.	IYO	Class II	1994-10-03
K924970	Feminine Heat Wrap	Conair LLC.	IRT	Class II	1994-10-03
K944090	Candela Alex Lazr Q-Switched Alexandrite Laser	Candela Corporation	GEX	Class II	1994-09-30
K943871	Aquaplast Tie Down Dressing	Anholt Technologies Inc.	LZM	Class I	1994-09-30
K943634	Hp 77010Cf	Hewlett-Packard Co.	IYO	Class II	1994-09-30
K943160	Interference Screw	Applied Osteo Systems, Inc.	HWC	Class II	1994-09-30
K943095	IV Transfer Spike	Simplivia Healthcare Ltd.	LHI	Class II	1994-09-30
K943023	Cvd Bullett Peripheral Infusion Catheter	Cardiovascular Dynamics, Inc.	FOZ	Class II	1994-09-30
K942953	Oracle MRI Whole Body Mr Imaging System	Otsuka Electronics USA, Inc.	LNH	Class II	1994-09-30
K942883	Digital I.d. Camera	Miles Inc., Agfa Division	JAC	Class I	1994-09-30
K942101	4-Lead Irrigation Set	Douglas Medical Products, Inc	HRX	Class II	1994-09-30
K941958	Western Dialysis Hemodialysis Concentrate	Western Dialysis Supplies, Ltd.	KPO	Class II	1994-09-30
K941814	Argyle Dual Lumen Umbilical Vessel Catheter	Sherwood Medical Co.	FOS	Class II	1994-09-30
K941099	Clean-Sorb	Hospital Specialty Co.	EFQ	Unclassified	1994-09-30