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 2568 of 3530

510(k) clearances, page 2568 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K900448	Cronex Quanta Rapid Sr397 Rare Earth Intens Screen	E.I. Dupont de Nemours & Co., Inc.	EAM	Class I	1990-02-16
K900280	Centriprep 100	Amicon, Inc.	JJP	Class I	1990-02-16
K900162	Dgh a-San Probe Holder	JEDMED Instrument Company	HDR	Class II	1990-02-16
K900161	A-Scan Roll-Around Stand	JEDMED Instrument Company	HMG	Class I	1990-02-16
K900131	Bio Flote(r)	Bio Clinic Co.	FNM	Class II	1990-02-16
K900070	Modified Uses of the Arthroscopic Surgical System	Dyonics, Inc.	HRX	Class II	1990-02-16
K900063	Multi-Channel Isolation Amplifier (Mcia)	Bio-Feedback Systems, Inc.	GWL	Class II	1990-02-16
K897099	Model 2800 Nd:yag Ophthalmic Laser	Alcon Surgical, Inc.	GEX	Class II	1990-02-16
K897065	Port Infusion Set (Pis) Infusion Set (Is)	Prn Services, Inc.	FPA	Class II	1990-02-16
K896949	Mobile X-Ray Personnel Protective Screens	Innovative Products Mfg.	EAK	Class I	1990-02-16
K896935	Convertors Breathable Gown Material Product Line	Baxter Healthcare Corporation	FYA	Class II	1990-02-16
K896845	Raichem(tm) Urea Nitrogen (Color) Reagent	Reagents Applications, Inc.	CDL	Class II	1990-02-16
K896797	Suction Catheter Kit	Westmark, Sterile Packing Systems, Inc. (Sps)	BSY	Class I	1990-02-16
K896784	Disposable Urodynamic Catheter Set	Life-Tech Intl., Inc.	KOD	Class II	1990-02-16
K896762	Sharplan Nd:yag Laser for Arthroscopy/meniscectomy	Sharplan Lasers, Inc.	GEX	Class II	1990-02-16
K896725	4 Sure Urological Catheter	The Boston & Pacific Co., Inc.	KOD	Class II	1990-02-16
K896666	P460, Dg32 Electroencephalograph	Teca, Inc.	GWQ	Class II	1990-02-16
K896623	Safecon Condoms - Pink Color	Quality Synthetics Intl, Inc.	HIS	Class II	1990-02-16
K896613	Flat Vascular Probe	Imex Medical Systems, Inc.	DPW	Class II	1990-02-16
K896587	Modified Hcg Enzyme Immunoassay Test Kit	Medix Biotech, Inc.	JHI	Class II	1990-02-16
K896567	Cantata Emg/evoked Response System	Dantec Medical, Inc.	GWF	Class II	1990-02-16
K896521	Modified Paramax Uric Acid Reagent	Baxter Healthcare Corporation	KNK	Class I	1990-02-16
K896440	Kenlor Pyrogallol Red Microprotein Assay Kit	Kenlor Industries, Inc.	JIR	Class I	1990-02-16
K896265	Quidel Group B Strep Test	Ortho-Clinical Diagnostics, Inc.	GTZ	Class I	1990-02-16
K896241	Cobas Ready Ldh Reagent	Roche Diagnostic Systems, Inc.	CFJ	Class II	1990-02-16
K896240	Cobas Ready Ck Reagent	Roche Diagnostic Systems, Inc.	JHY	Class II	1990-02-16
K896239	Cobas Ready Cholesterol Reagent	Roche Diagnostic Systems, Inc.	CHH	Class I	1990-02-16
K896238	Cobas Ready Ast Reagent	Roche Diagnostic Systems, Inc.	CIS	Class II	1990-02-16
K896237	Cobas Ready Alt Reagent	Roche Diagnostic Systems, Inc.	CKD	Class I	1990-02-16
K896234	Cobas Ready Stat Profile Reagent Strip	Roche Diagnostic Systems, Inc.	CKA	Class I	1990-02-16
K896233	Cobas Ready Liver Profile Reagent Strip	Roche Diagnostic Systems, Inc.	CIT	Class II	1990-02-16
K896231	Cobas Ready Triglyceride Reagent	Roche Diagnostic Systems, Inc.	CDT	Class I	1990-02-16
K896230	Cobas Ready Total Protein Reagent	Roche Diagnostic Systems, Inc.	CEK	Class II	1990-02-16
K896229	Cobas Ready Profile 1 Reagent Strip	Roche Diagnostic Systems, Inc.	CIT	Class II	1990-02-16
K896228	Cobas Ready Cardio Profile Reagent Strip	Roche Diagnostic Systems, Inc.	CIT	Class II	1990-02-16
K896227	Cobas Ready Uric Acid Reagent	Roche Diagnostic Systems, Inc.	KNK	Class I	1990-02-16
K896170	Rep Ck Isoforms Kit Cat. No. 3081, 3082, 3083	Helena Laboratories, Corp.	JHT	Class II	1990-02-16
K896160	Williams Penile Anesthetic Retainer	Cook Incorporated	FHA	Class I	1990-02-16
K896095	Images-on-Call Teleradiology System	Devices & Services Co.	LMD	Class I	1990-02-16
K895951	Cholesterol Test Kit	Elite Technology, Inc.	CHH	Class I	1990-02-16
K895890	Autopen	Ulster Scientific, Inc.	FMF	Class II	1990-02-16
K895772	Exel Indwelling Catheter	Exel Intl.	FDZ	Class I	1990-02-16
K895771	Exel Spinal Needles	Exel Intl.	FMI	Class II	1990-02-16
K895769	Exel Huber Needle	Exel Intl.	FMI	Class II	1990-02-16
K895768	Exel Safelet Catheter	Exel Intl.	FOZ	Class II	1990-02-16
K895335	Cronex Compact Mammography Cassette	E.I. Dupont de Nemours & Co., Inc.	IXA	Class II	1990-02-16
K895018	Surgical Gloves	Lon Tai Chemical Industrial Co., Ltd.	KGO	Class I	1990-02-16
K894734	Rhinotherm Ultra 2	Twinmed Products, Inc.	KFZ	Class I	1990-02-16
K893545	Ivex Model No. Bp 3000 Breastpump	Ivex Medical, Inc.	HGX	Class II	1990-02-16
K900565	Invacare Power 9000 Series Wheelchair	Invacare GmbH	ITI	Class II	1990-02-15