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 2330 of 3531

510(k) clearances, page 2330 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922275	Upsherscope(tm)	Upsher Laryngoscope Co.	CCW	Class I	1993-01-06
K921762	Shawnee Products Kit I	Absentee Shawnee Bandage Group	LRR	Not classified	1993-01-06
K914370	Meconium Suction Device (Msd)	Vital Signs, Inc.	BTR	Class II	1993-01-06
K926046	Dade(r) Ck-Mb/myoglobin Immun Control, I,ii,iii	Baxter Diagnostics, Inc.	JJY	Class I	1993-01-05
K923976	Ambu Single Patient Use PEEP Valve	Ambu, Inc.	BYE	Class II	1993-01-05
K923474	Low Profile Gastromstomy Device	Biosearch Medical Products, Inc.	KNT	Class II	1993-01-05
K921343	Cobe Patient Monitoring Products	LivaNova USA, Inc.	DRS	Class II	1993-01-05
K925133	Dpd-510 Therapeutic Radiation Dosimeter	Scanditronix, Inc.	IWB	Class II	1993-01-04
K925109	Abbott Tdx/tdxflx Tt4	Abbott Medical	CDX	Class II	1993-01-04
K925002	Urea Nitrogen Test	Em Diagnostic Systems, Inc.	CDQ	Class II	1993-01-04
K924879	Ep 3000	Oec-Diasonics, Inc.	JAA	Class II	1993-01-04
K924832	Olympus Creatine Kinase Reagent	Olympus Corp.	CGS	Class II	1993-01-04
K924244	Roche Reagent for Ast	Roche Diagnostic Systems, Inc.	CIT	Class II	1993-01-04
K923283	Sup 5415 Single Use Only Sterile Hospital Kit	Savoy Medical Supply Co., Inc.	KKX	Class II	1993-01-04
K921127	Panda Needle Catheter Jejunostomy Kit	Knight Medical, Inc.	KNT	Class II	1993-01-04
K920493	Peg Prep Tray	Sandoz Nutrition	KNT	Class II	1993-01-04
K921090	Isola(r) Transverse Rod Dual Connector	Acromed Corp.	KWP	Class II	1992-12-31
K920392	Isola Spine System: Plate-Rod Combination	Acromed Corp.	KWP	Class II	1992-12-31
K926082	Cardiac Stress Table, 056-180/Univ Roll Stress Att	Biodan Medical Systems, Ltd.	IZI	Class II	1992-12-30
K925903	Laparoscopic 5Mm Abc Probe, Modification	Birtcher Medical Systems, Inc.	GEI	Class II	1992-12-30
K925491	Barbiturate Eia Test	Diagnostic Reagents, Inc.	DIS	Class II	1992-12-30
K924995	4 Sure Tm Anesthesia Extension Set	Boston Pacific Medical, Inc.	BSO	Class II	1992-12-30
K924756	Mag Res Diag Devi Access Cir Polar(cp) Spine Coil	Siemens Medical Solutions USA, Inc.	LNH	Class II	1992-12-30
K924719	Ancor	Siemens Medical Solutions USA, Inc.	IZI	Class II	1992-12-30
K924708	Cinenet Cardiac Image Network	Sony Medical Systems	IZI	Class II	1992-12-30
K924107	Ercp Cannula	United States Endoscopy Group, Inc.	FGE	Class II	1992-12-30
K923402	Crystal Trace Piezo Respiratory Effort Sensor	Pro-Tech, Inc.	BZQ	Class II	1992-12-30
K923161	Braided Polyester Suture Material	Mitek Surgical Products, Inc.	GAS	Class II	1992-12-30
K921608	Presssion, Sequential	Chattanooga Group, Inc.	JOW	Class II	1992-12-30
K920880	Brainscan Brachytherapy Module	Brainlab, Inc.	KXK	Class II	1992-12-30
K914600	Neurological Sponge	I M, Inc.	HBA	Class II	1992-12-30
K925335	Acufex Intra Articular Measuring Device	Acufex Microsurgical, Inc.	HTJ	Class I	1992-12-29
K925171	Free Sun Pro Design 3000 and 3800	Free Sun Prod. AB	FTC	Class II	1992-12-29
K924728	Knot Pusher	Advanced Surgical, Inc.	GCJ	Class II	1992-12-29
K924659	Olyumpus Total Protein Reagent	Olympus Corp.	CEK	Class II	1992-12-29
K924590	Microwave Automated Tissue Processor	Innovative Medical Systems, Inc.	IEO	Class I	1992-12-29
K924262	Ena Screening Cie Kit for Diagnostic Use	The Binding Site	LLL	Class II	1992-12-29
K924006	Bartel Prima System Influenza a Enzyme Immunoassay	Baxter Healthcare Corporation	GNX	Class I	1992-12-29
K923878	Bivona Customized Tracheostomy Tubes	Bivona Medical Technologies	JOH	Class II	1992-12-29
K922845	Basic Dressing Change Tray Smp 102A	Specialty Medical Products Co.	FRG	Class II	1992-12-29
K921487	Marquette Series 360 Defibrillator	Marquette Electronics, Inc.	LDD	Class II	1992-12-29
K921327	Nature's Cradle Hm-10	Infant Advantage, Inc.	FMS	Class II	1992-12-29
K921279	Cd4 Cytospheres Kit	Coulter Electronics, Inc.	GKZ	Class II	1992-12-29
K920879	Brainscan Radiosurgery Module	Brainlab, Inc.	IYE	Class II	1992-12-29
K915073	Marquette Sv O2 Module	Marquette Electronics, Inc.	DQE	Class II	1992-12-29
K926015	Ckmb Control for Mass Measurement-Levels 1,2,3	Cala Diagnostics	JJX	Class I	1992-12-28
K925844	Philips Super Cp Family	Philips North America LLC	IZO	Class I	1992-12-28
K925801	Rep E-Z Ck-30 Isoenzyme Kit	Helena Laboratories, Corp.	CGS	Class II	1992-12-28
K925705	Accurad-200 System & Accurad-300 Plus System	Denar Corp.	IWY	Class I	1992-12-28
K925668	Creatinine Meth for Use on the Dimension Clin Chem	E.I. Dupont de Nemours & Co., Inc.	CGX	Class II	1992-12-28