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 2262 of 3531

510(k) clearances, page 2262 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K926174	Model 9100 H.r. Infant Scale	Acme Medical Scale Co.	FRW	Class I	1993-10-25
K926038	Flex-Tech Balloon Dilator	Cape Tech Medical Products	KNQ	Class II	1993-10-25
K923559	Steri-Cath Mdi	Concord/Portex	CAF	Class II	1993-10-25
K920205	Ott Insufflation Filter Tubing	Georgia Biomedical Research Group, Inc.	HIF	Class II	1993-10-25
K934121	Vista Folate Assay	Syva Co.	CGN	Class II	1993-10-22
K933695	Sigma Electrolyte Buffer	Sigma Chemical Co.	JFL	Class II	1993-10-22
K933464	Stratus Estradiol Fluorometric Enzyme Immunoassay	Baxter Diagnostics, Inc.	CHP	Class I	1993-10-22
K933329	King Diagnostics Iron and Total Iron Binding Capacity Reagent	King Diagnostics, Inc.	JMO	Class I	1993-10-22
K933269	Aia-Pack(r) Prog Assay	Tosoh Medics, Inc.	JLS	Class I	1993-10-22
K931228	Progesterone Radioimmunoassay Kit	IMMUNOTECH s.r.o.	JLS	Class I	1993-10-22
K930950	Gore-Tex Cardiovascular Patch & Surgical Membrane	W. L. Gore & Associates, Inc.	DXZ	Class II	1993-10-22
K930595	Axiom Total Knee Syst, Dual Dome All Poly Tib Tray	Orthomet, Inc.	JWH	Class II	1993-10-22
K930478	Readar	Alamar Biosciences, Inc.	LRG	Class II	1993-10-22
K926299	Contour Femoral Hip Stem W/hydroapatite Coating	Depuy, Inc.	MEH	Class II	1993-10-22
K926270	Mitek Ligament Anchor	Mitek Surgical Products, Inc.	JDR	Class II	1993-10-22
K921819	Edentec Model 3710 I Digital Printer	Edentec Corp.	BZQ	Class II	1993-10-22
K920438	Via 1-01 Infusion Pump Blood Chemistry System	Via Medical Corp.	LZF	Class II	1993-10-22
K934509	Pulmoguard Disposable Baterial/viral Filter	Sdi Diagnostics, Inc.	CAH	Class II	1993-10-21
K934475	Koko Filter II	Pulmonary Data Services Inst., Inc.	CAH	Class II	1993-10-21
K934357	Liquichek Routine Urime Chemistry Control, Levels 1 & 2	Bio-Rad	JJY	Class I	1993-10-21
K933388	Brimfield Precision Scissor	Springfield Surgical Instruments	GCJ	Class II	1993-10-21
K933243	Knot Pusher	Advanced Surgical, Inc.	GCJ	Class II	1993-10-21
K933069	Model Ep-2 Clinical Stimulator	Ep Medical, Inc.	DTA	Class II	1993-10-21
K931581	Glenn Bed	KCI USA, Inc.	FNL	Class II	1993-10-21
K931406	Powder-Free Patient Examination Gloves	P.T. Healthcare Glovindo	LYY	Class I	1993-10-21
K931185	Sensicath Point-of-Care Blood Gas Monitoring Syste	Optical Sensors, Inc.	CCC	Class II	1993-10-21
K924388	Angemed Model 4000 Qc Bipolar Temp Pacing Lead	Angemed, Inc.	LDF	Class II	1993-10-21
K923988	Sensormedics Model 2200 Pulmonary Function Labs	Sensor Medics Corp.	BZG	Class II	1993-10-21
K923289	Survalent II Oral Thermometer	Epson America, Inc.	FLL	Class II	1993-10-21
K922052	Tsa 2001 Thermal Sensory Analyzer	Medoc Corp.	LQW	Class I	1993-10-21
K914925	Medac System/3	Davicon, Inc.	HCC	Class II	1993-10-21
K933582	Profile Series 29 Files	Tulsa Dental Products LLC	EKS	Class I	1993-10-20
K933563	Vs 1A	Metalor Dental USA Corp.	EJS	Class II	1993-10-20
K933547	Intra-Oral Irrigator	Parkell, Inc.	ELC	Class II	1993-10-20
K933529	Eyeglasses Frames	Vistula Assistance & Consulting Bureau	HQZ	Class I	1993-10-20
K933459	Resiment with Fluoride	J.L. Blosser, Inc.	EMA	Class II	1993-10-20
K933166	A-Dec 2611 Assistant's Cart	A-dec, Inc.	EIA	Class I	1993-10-20
K933150	Noblepharma Dec 500 Straight Handpiece	Nobelpharma USA, Inc.	DZE	Class II	1993-10-20
K932774	Dw232 #31	Invoclar North America, Inc.	EJT	Class II	1993-10-20
K930956	Sigma-Brillen (or) Multiple	Sigma-Brillen	HQZ	Class I	1993-10-20
K930858	Modissa 90 S.r.l. Sunglasses	Modissa 90 SRL	HQY	Class I	1993-10-20
K930094	Aukusleeve	Aukland Medical Plastics, Inc.	EJB	Class I	1993-10-20
K925767	Branemark System Single Tooth Abutments,inst&comp.	Nobelpharma USA, Inc.	DZE	Class II	1993-10-20
K922806	Ormco Sportsguard	Ormco Corp.	EJF	Class I	1993-10-20
K920328	Amdent 2030, Polisher/scaler	Amdent AB	ELC	Class II	1993-10-20
K934540	Barrierflex-Pf Pulmonary Function Testing Filter	Bird Life Design	CAH	Class II	1993-10-19
K933365	Babistick	Graphic Controls Corp.	FMK	Class II	1993-10-19
K933106	Endoscope	Origin Medsystems, Inc.	ODF	Class II	1993-10-19
K931776	Diomed 25 25W Surgical Diode Laser	Dio-Med Corp.	GEX	Class II	1993-10-19
K931439	Ohmeda Model 5330 Anesthetic Monitor	GE Healthcare	CBQ	Class II	1993-10-19