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 2026-10-26, 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 2737 of 3530

510(k) clearances, page 2737 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880476	Lyme Disease Elisa	Hillcrest Biologicals	LSR	Class II	1988-04-26
K880305	Lifeport Low Profile Vascular Access Port W/cath.	Strato Medical Corp.	LJT	Class II	1988-04-26
K870910	Precision Spinal Adjuster Model 115	Kinetic Technology, Inc.	LXM	Unclassified	1988-04-26
K881429	Yankauer Suction Instru./laytex Gloves/suct. Cath.	Medical Repackers Co.	CAZ	Class II	1988-04-25
K881393	Rondex Rescue Mask	Rondex Products, Inc.	BSJ	Class I	1988-04-25
K881277	Pace System for Neisseria Gonorrhoeae Addi. Claims	Hologic, Inc.	LSL	Class II	1988-04-25
K881141	Pharmaseal Isoflex Anesthesia Breathing Circuit	Baxter Healthcare Corporation	CAI	Class I	1988-04-25
K881105	Culture Collection Device	Medical Packaging Corporation	JSM	Class I	1988-04-25
K880766	Reliance Metal Primer	Reliance Orthodontic Products, Inc.	DYH	Class II	1988-04-25
K880735	Unscented Menstrual Pads	Personal Products Co.	HHD	Class I	1988-04-25
K880734	Scented or Scented Deodorized Menstrual Pads	Personal Products Co.	HHI	Class II	1988-04-25
K880592	Laseguide 600A, 600B, 400A, 400B for Pulmonary Use	Laser Peripherals LLC	LLO	Class II	1988-04-25
K880479	Imed(r) Gemini(tm) Pc-1 Volumetric Infusion Pump	Imed Corp.	FRN	Class II	1988-04-25
K880217	Ssd-870 Cardio Vascular Phased Array Sector Scann.	GE Medical Systems Information Technologies, Inc.	DXK	Class II	1988-04-25
K880204	Cadd-Tpa(tm) Model 5600 Ambulatory Infusion Pump	Pharmacia Deltec, Inc.	FRN	Class II	1988-04-25
K874750	Video Analyzer 4000	Scientific Imaging, Inc.	IBJ	Class I	1988-04-25
K874685	Trans-Scan 3-D Transcranial Doppler	Carolina Medical Electronics	IYO	Class II	1988-04-25
K874684	Tc2-64B Transcranial Doppler	Carolina Medical Electronics	IYO	Class II	1988-04-25
K874573	Fresenius Puristeril 340 (Tm)	Seratronics, Inc.	LIF	Class II	1988-04-25
K881509	Leukopor(tm) Surgical Tape	Beiersdorf, Inc.	KGX	Class I	1988-04-22
K880981	A2j Mz 44 B Type	A2j, Inc.	IWE	Class I	1988-04-22
K880768	Mic (Specific Line) Replacement Kit	Medical Innovations, Inc.	KNT	Class II	1988-04-22
K880310	Angio Drape Pack Acp-010Fm	Arrow Intl., Inc.	DXT	Class II	1988-04-22
K880298	Peripheral Dilatation Catheter	Medi-Tech, Inc.	LIT	Class II	1988-04-22
K874739	Electric Mobility's Sparky	Electric Mobility	ITI	Class II	1988-04-22
K873702	Rei-38 Radiographic Table	Radiological Engineering, Inc.	IXQ	Class II	1988-04-22
K870878	Eub-305 Diagnostic Ultrasound Device	Hitachi Medical Corp. of America	DXK	Class II	1988-04-22
K870088	S-Rom Supercup Acetabular Cup	Joint Medical Products Corp.	LWJ	Class II	1988-04-22
K881675	Immulon 4 Flat Bottom Plates & Removawell Strips	Dynatech Laboratories, Inc.	JZQ	Class I	1988-04-21
K881659	Tissue Section Adhesive	Surgipath Medical Industries, Inc.	IFZ	Class I	1988-04-21
K881649	Modified Paracon(tm) Concentration Kit	Para Scientific Co.	LKS	Class I	1988-04-21
K881465	Cryobiological Freezer	Cryodyne Technologies, Inc.	KSP	Class I	1988-04-21
K881457	Kodak Surecell Strep a Test Kit	Eastman Kodak Company	GTZ	Class I	1988-04-21
K881452	Folding Wheelchair	Health Care Innovations, Inc.	IOR	Class I	1988-04-21
K881434	Heart Check Apolipoprotein a-1	Northwest Biotech	MSJ	Class I	1988-04-21
K881433	Heart Check Apolipoprotein-B	Northwest Biotech	MSJ	Class I	1988-04-21
K881413	Electro-Cautery Suction Tube	Alto Development Corp	GEI	Class II	1988-04-21
K881410	The Adventurer	Westport Mobility Products, Inc.	IOR	Class I	1988-04-21
K881388	Kin-Com Jr	Chattanooga Group, Inc.	LBB	Class II	1988-04-21
K881339	Nova Lite(tm) Ana Plus	Inova Diagnostics, Inc.	LLL	Class II	1988-04-21
K881333	Olympia Alloy	J.F. Jelenko & Co., Inc.	EJJ	Class II	1988-04-21
K881331	Orthodontic Nitinol Springs	Flexmedics	EJW	Class I	1988-04-21
K881298	Assist-a-Lift	Action Engineering, Inc.	INO	Class II	1988-04-21
K881256	Non Coring Infusion Set	Taris Corp.	LJT	Class II	1988-04-21
K881253	Rotory Scaler Swivel Improvement Feature, Titan Sw	Dentalez Group	ELC	Class II	1988-04-21
K881242	Cell-Dyn Rapid-Lyse and Hemogloblin	Abbott Diagnostics	GJZ	Class II	1988-04-21
K881138	Clinical Assays Gammacoat [125I] Ferritin Immuno.	Baxter Healthcare Corporation	JMG	Class II	1988-04-21
K881127	Qm300 Calibrator D Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DCF	Class II	1988-04-21
K881112	Fungi Histology Control Slides	Sigma Diagnostics, Inc.	LJG	Class I	1988-04-21
K881109	Spirochetes Histology Control Slides	Sigma Diagnostics, Inc.	LJG	Class I	1988-04-21