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 2602 of 3530

510(k) clearances, page 2602 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K894907	Mark IV Hand, Thumb and Wrist (Cpm) Unit	Innovative Medical Engineering, Inc.	BXB	Class I	1989-10-06
K894827	Automix 3+3 Compounder	Baxter Healthcare Corporation	LHI	Class II	1989-10-06
K894365	Single Patient Use Disposable Manual Resuscitator	Medtronic, Inc.	BTM	Class II	1989-10-06
K894334	Second Generation Knee System	Orthomet, Inc.	JWH	Class II	1989-10-06
K894309	Ohmeda Modulus Cd Anesthesia System	GE Healthcare	BSZ	Class II	1989-10-06
K894247	Periodontal Irrigating Solution-D	Dentsply Intl.	ELC	Class II	1989-10-06
K894244	Devilbiss Model 8500D and 8500D-608	Devilbiss Health Care, Inc.	CCQ	Class I	1989-10-06
K893964	Spectrastim Tm 1000	Therapeutic Technologies, Inc.	IPF	Class II	1989-10-06
K893205	First Choice (Tm)	Polymer Technology Corp.	CGA	Class II	1989-10-06
K892903	Mitek Anchor Drill	Mitek Surgical Products, Inc.	HTW	Class I	1989-10-06
K892885	Resubmitted Rd1000 Neopuff Infant Resuscitator	Fisher & Paykel Electronics, Ltd.	BTL	Class II	1989-10-06
K892228	Intermedics High Tibial Osteotomy System	Intermedics Orthopedics	HRS	Class II	1989-10-06
K895746	Sharplan Model 710 Microspot	Sharplan Lasers, Inc.	GEX	Class II	1989-10-05
K895693	Fortress 2000Fs 3-Wheel Scooter	Fortress Scientific, Ltd.	INI	Class II	1989-10-05
K895595	Fortress 655Fs Power Wheelchair	Fortress Scientific, Ltd.	ITI	Class II	1989-10-05
K894841	Iris Oculight(tm) Sl	Iriderm Div.	GEX	Class II	1989-10-05
K894806	Siemens Endo-P-Probe	Siemens Medical Solutions USA, Inc.	IYO	Class II	1989-10-05
K894490	Sterile Ultrasound Transmission Gel	Swedish Trade Council USA	JOT	Class II	1989-10-05
K894489	Gynecologic Examination Kit	A & A Medical, Inc.	HIB	Class II	1989-10-05
K894453	Latex Patient Examination Gloves	Mittal Meditex Pvt., Ltd.	LYY	Class I	1989-10-05
K894361	Lifecare Pressure Alarm Cat. No. 34-010	Lifecare Services, Inc.	CAP	Class II	1989-10-05
K894321	Model 285 Infusion Pump	3M Company	FRN	Class II	1989-10-05
K892888	Extaciser Perineal Muscle Exerciser	Bivona Medical Technologies	HIR	Class II	1989-10-05
K892841	Bedfont Ec50 Smokerlyzer Carbon Monoxide Monitor	Bedfont Technical Instruments, Ltd.	CCJ	Class II	1989-10-05
K892639	The Original Pulse-Pak	Jones Sales Co.	NFB	Class II	1989-10-05
K891449	Sonoline Cf	Siemens Ultrasound, Inc.	IYO	Class II	1989-10-05
K891315	Attenuating Surgical Glove	F & L Medical Products LLC	LZC	Class I	1989-10-05
K895641	Nil Patient Examination Gloves	United Lion Rubber Industries Sdn. Bhd.	LYY	Class I	1989-10-04
K895582	Qclyte Protein-Based Ise Control	Baxter Healthcare Corporation	JJR	Class I	1989-10-04
K895484	Stratus(r) Gentamicin Fluorometric Enzyme Immuno.	Baxter Healthcare Corporation	LCD	Class II	1989-10-04
K895474	Non-Mydriatic Retinal Camera, Cr4-45Nm Dual	Canon Medical Components U.S.A., Inc.	HKI	Class II	1989-10-04
K895423	Access Chemistry Analyzer	American Monitor Corp.	JJE	Class I	1989-10-04
K895339	Anti-Ss-a (Ro) and Anti-Ss-B (La) Antibody Test	Immco Diagnostics, Inc.	LLL	Class II	1989-10-04
K895332	Latex Examination Gloves	Ever Glory Intl., Inc.	LYY	Class I	1989-10-04
K895240	Delfia Plate Fluorometer 1232	Pharmacia, Inc.	KHO	Class I	1989-10-04
K894709	Nidek Model Adc-8000	Nidek, Inc.	GEX	Class II	1989-10-04
K894677	Latex Examination Gloves	Kumpulan Santra (Penang) Sdn. Bhd.	LYY	Class I	1989-10-04
K894587	Mascot Examination Gloves	Mascot, Inc.	LYY	Class I	1989-10-04
K894575	Technicon Ra System Thyroxine T4 Method	Technicon Instruments Corp.	CDX	Class II	1989-10-04
K894421	Woldoff Prismatic Biconcave Lens	Ocular Instruments, Inc.	HJK	Class II	1989-10-04
K894420	Ortho Result Plus/pregnancy	Ortho Diagnostic Systems, Inc.	JHI	Class II	1989-10-04
K894360	Model 280 Infusion Pump	3M Company	FRN	Class II	1989-10-04
K894331	Osseodent Surgical Kit	Collagen Corp.	DZE	Class II	1989-10-04
K894320	Model 480 Infusion Pump	3M Company	FRN	Class II	1989-10-04
K894204	Calcium (Arsenazo III) Reagent	Sigma Diagnostics, Inc.	CJY	Class II	1989-10-04
K892998	Patient Examination Gloves	Shen Yunn Plastics Corp.	LYY	Class I	1989-10-04
K892996	Patient Examination Gloves	Multiplus Trading, Ltd.	LYY	Class I	1989-10-04
K892665	Pro-Ject(tm) Safety Needle Holder	Pro-Tec Containers, Inc.	JKA	Class II	1989-10-04
K892609	Patient Examination Gloves (Latex)	Commfields (M) Sdn. Bhd.	LYY	Class I	1989-10-04
K892608	Patient Examination Gloves (Latex)	Grand Design Sdn. Bhd.	LYY	Class I	1989-10-04