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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 275 of 3528

510(k) clearances, page 275 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K221853	OTC Ddr	Konica Minolta, Inc.	KPR	Class II	2022-07-27
K221687	Pegasus-X Expandable PLIF System	GS Medical Co., Ltd.	MAX	Class II	2022-07-27
K221464	CorPath GRX System	Corindus, Inc.	DXX	Class II	2022-07-27
K221430	reVive Light Therapy LED Cleansing System	LED Technologies, Inc.	OHS	Class II	2022-07-27
K221271	Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)	Shandong Maida Medical Technology Co., Ltd.	LZA	Class I	2022-07-27
K221269	Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	Better Care Plastic Technology Co., Ltd.	LZA	Class I	2022-07-27
K221254	Hummingbird Tympanostomy Tube System	Preceptis Medical, Inc	ETD	Class II	2022-07-27
K220958	Real Intelligence Cori	Blue Belt Technologies, Inc.	OLO	Class II	2022-07-27
K220922	Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit	Cochlear Americas	PFO	Class II	2022-07-27
K220886	Upper Arm Type Blood Pressure Monitor	Shenzhen Jamr Technology Co., Ltd	DXN	Class II	2022-07-27
K220876	AOK 95A Medical Mask (20200049)	AOK Tooling Limited	FXX	Class II	2022-07-27
K214007	HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap	Owens & Minor (O&M) Halyard, Inc.	FRG	Class II	2022-07-27
K213507	AquaA	Fresenius Medical Care Rental Therapies Group, LLC	FIP	Class II	2022-07-27
K213252	Dornier Thulio	Dornier Medtech America, Inc.	GEX	Class II	2022-07-27
K211496	TransLoc 3D	Foundation Fusion Solutions, LLC (dba Cornerloc)	OUR	Class II	2022-07-27
K211385	KeriFlex® MCP and PIP Finger Joint Prostheses	Keri Medical	KYJ	Class II	2022-07-27
K210902	EliA Ro52, EliA Ro60	Phadia AB	LKJ	Class II	2022-07-27
K210822	DeepRhythmAI	Medicalgorithmics S.A.	DQK	Class II	2022-07-27
K221939	Cemented Round Patella with JRNY Pegs	Smith & Nephew, Inc.	JWH	Class II	2022-07-26
K221572	VyPlate Anterior Cervical Plate System	VY Spine, LLC	KWQ	Class II	2022-07-26
K221567	LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)	Qingdao Hisense Medical Equipment Co.,Ltd.	PGY	Class II	2022-07-26
K221502	Parcus Synd-EZ SS	Parcus Medical, L.L.C.	MBI	Class II	2022-07-26
K221404	Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)	ConforMIS, Inc.	JWH	Class II	2022-07-26
K214112	Invia Ease Negative Pressure Wound Therapy (NPWT) System	Medela AG	OMP	Class II	2022-07-26
K213858	LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus	Diasorin Inc.	NXO	Class II	2022-07-26
K212407	Gastric Lightguide (GLG)	Naser Dib Gabinet Lekarksi Nasmed	KNT	Class II	2022-07-26
DEN210032	AccuMeasure System	Rqmis Inc.	QTH	Class II	2022-07-26
K221460	BioFire COVID-19 Test 2	BioFire Defense, LLC	QQX	Class II	2022-07-25
K221409	Paneffort 3-ply Surgical and Procedural Masks	Paneffort, LLC	FXX	Class II	2022-07-25
K220808	Tigertriever 13 Revascularization Device	Rapid Medical Inc.	NRY	Class II	2022-07-25
K220606	Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2	Ambu A/S	EOQ	Class II	2022-07-25
K220439	Viz SDH	Viz. Ai, Inc.	QAS	Class II	2022-07-25
K221877	Powder-Free Nitrile Examination Glove, Non-Sterile	Goodgloves Industries Sdn Bhd	LZA	Class I	2022-07-23
K221535	Align Lumbar Interbody Fusion System	Acuity Surgical Devices, LLC	MAX	Class II	2022-07-22
K221525	PreXion3D Explorer PRO	Prexion Corporation	OAS	Class II	2022-07-22
K221461	10Hq701g-B	LG Electronics.Inc	MQB	Class II	2022-07-22
K221394	14Hq701g-B	LG Electronics.Inc	MQB	Class II	2022-07-22
K221234	TargetCool	Recensmedical Inc.	GEH	Class II	2022-07-22
K221196	Disposable Medical Face Mask (ear loop)	Xiantao Topmed Nonwoven Protective Products Co., Ltd	FXX	Class II	2022-07-22
K220940	EchoPAC Software Only, EchoPAC Plug-in	GE Healthcare	QIH	Class II	2022-07-22
K220906	Secure-Lock	Xiros Ltd	HTY	Class II	2022-07-22
K220882	Vivid E80, Vivid E90, Vivid E95	GE Medical Systems Ultrasound and	IYN	Class II	2022-07-22
K220624	AI4CMR v1.0	AI4MedImaging Medical Solutions S.A.	LLZ	Class II	2022-07-22
K220486	Kentrospine PSS Pedicle Screw System	Rivarp Medical Private Limited	NKB	Class II	2022-07-22
K220216	C-Stem AMT LE Prosthesis	Depuy Ireland UC	JDI	Class II	2022-07-22
K220064	Synergy Marble (Model: Opasm)	Yrs Group, Inc.	OHS	Class II	2022-07-22
K213922	Fx Sps	Pixee Medical	LLZ	Class II	2022-07-22
K213813	DuraFuse Clip and Applier System	Neuramedica Inc.	FZP	Class II	2022-07-22
K212975	MedWand	Medwand Solutions, Inc	MWI	Class II	2022-07-22
K211891	DM Converter - TiN coated	Medacta International SA	LZO	Class II	2022-07-22