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 1582 of 3531

510(k) clearances, page 1582 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K012033	Multifunction Endoscopic Instrument	Seedling Enterprises., LLC	GEI	Class II	2001-09-20
K012010	Modification to Lr 5200 Film Recorder	Agfa Corp.	LMC	Class II	2001-09-20
K011988	Surgical Lightstic 180, Model 180 L, Model 180 C	CardioFocus, Inc.	OCL	Class II	2001-09-20
K011964	Insight Millennium Plus	Fasstech	HCC	Class II	2001-09-20
K011223	Quantum Versatility (Qvs) Dental Implant System	Paxmed International, LLC	DZE	Class II	2001-09-20
K010981	Gsa Genito Sensory Analyzer	Medoc Ltd. Advanced Medical Systems	LLN	Class I	2001-09-20
K002241	Quantum Versatility (Qvs) Dental Implant System	Quantum Bioengineering, Ltd.	DZE	Class II	2001-09-20
K000122	Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3x,6x (1,3 or 6 Strips per Box)	Neucoll, Inc.	MQV	Class II	2001-09-20
K012927	M71 Power Wheelchair	Invacare GmbH	ITI	Class II	2001-09-19
K012515	Bifurcated Vaccinating Needle	Precision Medical Products	SCL	Class II	2001-09-19
K012393	Tina-Quant Transferrin Ver.2	Roche Diagnostics GmbH	DDG	Class II	2001-09-19
K012371	Tina-Quant Transferrin Ver.2	Roche Diagnostics GmbH	DDG	Class II	2001-09-19
K012334	Contour Meniscus Arrow, Models 541110, 541113, and 541116	Bionx Implants, Inc.	MAI	Class II	2001-09-19
K012301	Immulite 2000 Digoxin, Models L2kdi2 (200 Tests) and L2kdi6 (600 Tests)	Siemens Healthcare Diagnostics Inc.	KXT	Class II	2001-09-19
K012260	Wiener Lab. Urea UV Cinetica Aa	Wiener Laboratories Saic	CDQ	Class II	2001-09-19
K012201	Premicron Nonabsorbable Pet Surgical Suture	Aesculap Inc	GAT	Class II	2001-09-19
K012165	Oldelft Thorascan Model Number 180T	Nucletron BV	KPR	Class II	2001-09-19
K012154	Aurora Magnetic Resonance Diagnostic Device	Aurora Imaging Technology, Inc.	LNH	Class II	2001-09-19
K012153	Lowsley Suprapubic Tractor	Circon Video	KOB	Class II	2001-09-19
K012124	Mersilk Black Silk Braided Non-Absorbable Suture, Usp	Johnson & Johnson Medical (China), Ltd.	GAP	Class II	2001-09-19
K012079	Geodesic EEG System, Model 200	Electrical Geodesics, Incorporated	GWQ	Class II	2001-09-19
K012047	3I Calcium Sulfate Bone Cement	ZimVie US Corp LLC	LYC	Class II	2001-09-19
K012007	Rhs Helmet	Restorative Health Svs, Inc.	MVA	Class II	2001-09-19
K011996	Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus	Procter & Gamble Co.	HIL	Class II	2001-09-19
K011975	Horizon Outlook with Dosecom	B.Braun Medical, Inc.	FRN	Class II	2001-09-19
K011954	Sulzer Orthopedics Allegretto Unicompartmental Knee	Sulzer Orthopedics, Inc.	HSX	Class II	2001-09-19
K011944	Dyonics Vision 635 Digital Capture System, Model 7209088	Smith & Nephew, Inc.	GCJ	Class II	2001-09-19
K011943	Impro Vise Absorbable Cement Flow Restrictor	DSM Biomedical, Inc.	LZN	Class II	2001-09-19
K011241	Neurosoft's Source	Neurosoft Ltd	OLX	Class II	2001-09-19
K011087	Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe	DSM Biomedical, Inc.	FMF	Class II	2001-09-19
K003620	Nsi Hexed and Non-Hexed Implant System	Nsi	DZE	Class II	2001-09-19
K012978	Randox Gentamicin	Randox Laboratories, Limited	LCD	Class II	2001-09-18
K012899	Green Nitrile Powder-Free Medical Exmaination Glove	Best Manufacturing Company	LZA	Class I	2001-09-18
K012842	V*care Manual Resuscitator	Salter Labs	BTM	Class II	2001-09-18
K012802	Mp3cf Electric Wheelchair	Merits Health Products, Inc.	ITI	Class II	2001-09-18
K012775	Ge Positrace/discovery VI Pet/ct Dual Mode Oncology Scanner	GE Healthcare	KPS	Class II	2001-09-18
K012768	Hemosil Recombi Plastin	Instrumentation Laboratory Co.	GJS	Class II	2001-09-18
K012722	Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek Coagulation Level 3, Models 781,782,783	Bio-Rad	GGN	Class II	2001-09-18
K012711	Disposable Powder Free Vinyl Patient Examination Gloves	Shijiazhuang Brilliance Plastic Co., Ltd.	LYZ	Class I	2001-09-18
K012413	Macropore Fx, Ps, Ns, Lp	Macropore Biosurgery, Inc.	JEY	Class II	2001-09-18
K012351	Bdprobetec Et Ct/gc Amplified DNA Assay	Becton Dickinson & Co	LSL	Class II	2001-09-18
K012168	Advance Medical Designs Fluid Pouch	Advance Medical Designs Inc	KKX	Class II	2001-09-18
K012152	Ds30 Hcy Blood Collection Tubes	Drew Scientific, Ltd.	GIM	Class II	2001-09-18
K011929	Handpiece Sheath-Model #A910	Aaron Medical, Inc.	GEI	Class II	2001-09-18
K011434	G7 Automated Hplc Analyzer	Tosoh Medics, Inc.	LCP	Class II	2001-09-18
K010851	Harrison Hand Held Adjusting Instrument	Harrison Cbp Seminars	LXM	Unclassified	2001-09-18
K012898	Modification to: Csc14 Blood Cardioplegia System	LivaNova USA, Inc.	DTR	Class II	2001-09-17
K012558	Powder Free Latex Patient Examination Gloves with Aloe Vera and Protein Content Labeling Claim of 50 Micrograms or Less	Matang Mfg. Sdn. Bhd.	LYY	Class I	2001-09-17
K012300	Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test Device	Acon Laboratories, Inc.	JXM	Class II	2001-09-17
K012125	Opus Magnum Anchor & Inserter	Opus Medical, Inc.	HTY	Class II	2001-09-17