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 2026-10-29, 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 2610 of 3530

510(k) clearances, page 2610 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K894177	Needle*less Drug Vial Adapter	Baxter Healthcare Corporation	FMF	Class II	1989-09-12
K894163	Phase 2 Transcranial Probe	Biosound, Inc.	IYN	Class II	1989-09-12
K894054	5.0 Mhz Array Intravaginal Transducer	Advanced Technology Laboratories, Inc.	IYN	Class II	1989-09-12
K894018	Reliance(r) 6200 Examination Chair	Haag-Streit USA Inc	HME	Class I	1989-09-12
K893796	Disposable Vinyl (PVC) Examination Gloves	Anmei Plastic & Rubber Products Co., Ltd.	LYZ	Class I	1989-09-12
K893339	Latex Examination Gloves	Kenmark Industrial Co., Ltd.	LYY	Class I	1989-09-12
K893235	Latex Examination Gloves	Quingdao Latex Factory	LYY	Class I	1989-09-12
K892501	Wright Medical Fetasafe	Wright Medical	HGM	Class II	1989-09-12
K892386	Diagnostic Ultrasound System: Model Ssa-250A	Toshiba America Medical Systems, In.C	IYO	Class II	1989-09-12
K892035	Patient Examination Glove (Latex)	Fine Spring Ent. Co., Ltd.	LYY	Class I	1989-09-12
K891582	Modified Osteoanalyzer (# Spsha110/220)	Osteon, Inc.	KGI	Class II	1989-09-12
K891575	Compat Enteral Feed Pump 199235 & 199240	Sandoz Nutrition	LZH	Class II	1989-09-12
K891231	Optima Mpt and Spt Pacemakers	Telectronics, Inc.	DXY	Class III	1989-09-12
K890959	Guidewire	Guidewire Technologies, Inc.	DQX	Class II	1989-09-12
K890400	Modified Urinary Catheter Introducer (Uci)	Go Medical Industries Pty., Ltd.	KOD	Class II	1989-09-12
K884692	The Safegard Personal Protection Kit	The Safegard Protection Corp.	HIS	Class II	1989-09-12
K895165	Ziggy Medichair	Laszlo Corp.	INM	Class I	1989-09-11
K895121	Intermedics Power Broach Impactor	Intermedics Orthopedics	HSZ	Class I	1989-09-11
K895107	Ace Orthopaedic Washers	Buckman Co., Inc.	HTN	Class II	1989-09-11
K895016	Model #510/515 General Transport Stretcher	Midmark Corp	INW	Class I	1989-09-11
K895015	Artromot(tm) Cpm Devices	Buckman Co., Inc.	BXB	Class I	1989-09-11
K895010	Mentor Spectacle Binocular Indirect Ophthalmoscope	Mentor O & O, Inc.	HLI	Class II	1989-09-11
K894927	Surgi Squeez	Ethox Corp.	KZD	Class I	1989-09-11
K894770	Personal Back with Fip Kit	Canadian Posture and Seating Centre, Inc.	KNN	Class I	1989-09-11
K894427	Disposable IV Induction Cover	Central Plastic, Inc.	FMK	Class II	1989-09-11
K894399	Sterigage Integrator Test Pack for Steam Sterili.	Pymah Corp.	FRC	Class II	1989-09-11
K894398	Sterigage Integrator Test Pack for Ethylene Oxide	Pymah Corp.	FRC	Class II	1989-09-11
K894124	Omnifit Self Tapping Cancellous Bone Screws	Osteonics Corp.	HWC	Class II	1989-09-11
K894025	Vinyl Examination Gloves (Non-Sterile)	Good Glove Corp.	LYZ	Class I	1989-09-11
K893968	Vkg 2000 Video Keratometer	Technitex, Inc.	HJA	Class I	1989-09-11
K893932	Latex Examination Gloves	Ngai Hing Latex Gloves Mfg. Co.	LYY	Class I	1989-09-11
K893872	P.f.c. Hip System Porous Coated Femoral Component	Johnson & Johnson Professionals, Inc.	KWY	Class II	1989-09-11
K893833	Ai 5200 Diagnostic Ultrasound System W/doppler	Acoustic Imaging	IYN	Class II	1989-09-11
K893294	Powder Free Vinyl (PVC) Exam Gloves	King Handy Five Corp.	LYZ	Class I	1989-09-11
K893280	Profect Examination Gloves	Shanghai Latex Factory	LYY	Class I	1989-09-11
K893279	Latex Examination Gloves	Safetytech Sdn. Bhd.	LYY	Class I	1989-09-11
K893159	Globe Patient Examination Gloves	Lucky and Happy, Inc.	LYY	Class I	1989-09-11
K893100	Vinyl Examination Gloves	Tong Shiung Plastics Industry	LYZ	Class I	1989-09-11
K893095	Sterile Patient Examination Gloves (Latex)	Asia Way Trading, Inc.	LYY	Class I	1989-09-11
K892684	Patient Examination Gloves (Latex)	Baldur Systems Corp.	LYY	Class I	1989-09-11
K892623	Patient Examination Gloves (Latex)	Globe Ent., Inc.	LYY	Class I	1989-09-11
K892620	Patient Examination Gloves (Latex)	Permark Sdn. Bhd.	LYY	Class I	1989-09-11
K892182	Patient Exam Gloves (Mfg. Shanghai - Changzheng)	Grand Monde Trading Co., Inc.	LYY	Class I	1989-09-11
K891509	Patient Examination Gloves (Latex)	Delaware Industries, Inc.	LYY	Class I	1989-09-11
K890178	Wheelchair Stump Support	Gerber Chair Mates, Inc.	KNN	Class I	1989-09-11
K894845	(Calas(tm)) W/add'l Reagent Calas(tm) Pronase	Meridian Diagnostics, Inc.	GMD	Class II	1989-09-08
K894829	Cefixime 5 Mcg Sensitivity Disks	Difco Laboratories, Inc.	JTN	Class II	1989-09-08
K894788	Dmi Series 90 Examination Table	M.D. Intl., Inc.	KMN	Class I	1989-09-08
K894690	CPAP Mask	Devilbiss Health Care, Inc.	BYE	Class II	1989-09-08
K894612	Intertech Newborn Hyperinflation Bag System	Intertech Resources, Inc.	NHK	Class II	1989-09-08