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 2012 of 3531

510(k) clearances, page 2012 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955907	Boehringer Mannheim Iga Assay	Boehringer Mannheim Corp.	CZP	Class II	1996-02-09
K955906	Boehringer Mannheim Igg Assay	Boehringer Mannheim Corp.	DFZ	Class II	1996-02-09
K955850	Pro-Tech	Central Solutions, Inc.	LRJ	Class I	1996-02-09
K955814	Cedia Dau Lsd Assay	Microgenics Corporation	DLB	Class II	1996-02-09
K955813	Cedia Dau Lsd Calbirators	Microgenics Corporation	DLJ	Class II	1996-02-09
K955787	Digitrace Home Video System	New England Medical Instruments, Inc.	OMB	Class II	1996-02-09
K955780	Rigidyne a External Fixation System	Zimmer GmbH	JDW	Class II	1996-02-09
K955675	Synchron Systems Propoxyphene Reagent	Beckman Instruments, Inc.	JXN	Class II	1996-02-09
K955570	Innofluor Amikacin Assay System	Oxis Intl., Inc.	KLQ	Class II	1996-02-09
K955569	Innofluor Gentamicin Assay System	Oxis Intl., Inc.	LCQ	Class II	1996-02-09
K955480	Bozotta Reinsertion Forceps	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1996-02-09
K955427	3I Titanium Plasma Sprayed Standard Threaded & Self-Tapping Implants	ZimVie US Corp LLC	DZE	Class II	1996-02-09
K955400	Quegel Hydrophilic Wound Dressing	Questor Pharma, Inc.	MGQ	Unclassified	1996-02-09
K955396	Stainless Steel Greenfield Vena Cava Filter with 12F Flexcarrier Introducter System	Boston Scientific Corporation	DTK	Class II	1996-02-09
K955255	Shimadzu Whole Body X-Ray CT Scanner Sct-7000Tx	Shimadzu Medical Systems	JAK	Class II	1996-02-09
K955230	Vascutek Gelsoft Plus Vascular Graft	Vascutek, Ltd.	DSY	Class II	1996-02-09
K955173	Sscs (Segmental Spinal Correction System)	Osteotech Inc	KWP	Class II	1996-02-09
K955171	Nexlock Femoral Stem	Nexmed, Inc.	JDG	Class II	1996-02-09
K955170	Nexflex Femoral Stem, Standard Design	Nexmed, Inc.	LPH	Class II	1996-02-09
K955158	Surgitron	Ellman Intl., Inc.	HQR	Class II	1996-02-09
K955157	Prospect Giardia/cryptosporidium Microplate Assay	Alexon Biomedical, Inc.	MHI	Class II	1996-02-09
K955085	Hm-Cap Eia Test (Modification)	Schiff & Co.	LYR	Class I	1996-02-09
K954864	Aslan Modular Instrument	Aslan Medical Technologies, Ltd.	GCJ	Class II	1996-02-09
K954682	Washer, Bolt, Nut, Orthopedic	Linvatec Corporation	HTN	Class II	1996-02-09
K953505	Burnaid Burn First Aid Dressing	Rye Pharmaceuticals Pty., Ltd.	MGQ	Unclassified	1996-02-09
K953489	Drager Infant Radiant Warmern Rh600	Drager, Inc.	FMT	Class II	1996-02-09
K953128	Suture Cord	Phoenix Biomedical Corp.	GAS	Class II	1996-02-09
K953124	Mayfield Radiolucent 2000 Skull Clamp	Ohio Medical Instrument Co., Inc.	HBL	Class II	1996-02-09
K952967	Unimed Medical Dispensing Pump	A.Z.E. Medical, Inc.	FRN	Class II	1996-02-09
K952668	Chrom Z-F:viii, Cat. No. 5241	Helena Laboratories, Corp.	GGP	Class II	1996-02-09
K952523	Cardiolipin Igg Eia Test Kit	Immunoprobe, Inc.	MID	Class II	1996-02-09
K952522	Cardiolipin Iga Eia Test System	Immunoprobe, Inc.	MID	Class II	1996-02-09
K952521	Cardiolipin Igm Eia Test System	Immunoprobe, Inc.	MID	Class II	1996-02-09
K952337	Roche Unimate 3/Unimate 5 Hba1c, Hba1c Calibrator, Hba1c Controls N & P	Roche Diagnostic Systems, Inc.	LCP	Class II	1996-02-09
K951164	Cd Liberty Posterior Spincal System	Sofamor Danek USA,Inc.	KWP	Class II	1996-02-09
K950723	Ambulatory (Holter) Recording System	Biosensor Corp.	DQK	Class II	1996-02-09
K943315	Ultrasound Scanner 2002	B & K Medical A/S	IYO	Class II	1996-02-09
K942210	Puritan-Bennett 335 Respiratory Support System	Medtronic, Inc.	MNS	Class II	1996-02-09
K936006	Saltime Viscometer	Harold J. Kosasky, M.D.	LHZ	Class I	1996-02-09
K960021	Calcitek Ha-Coated Endosseous Dental Implant Systems	Calcitek, Inc.	DZE	Class II	1996-02-08
K955914	Limited Reuse Arthroscopic Blades	Smith & Nephew Dyonics, Inc.	HRX	Class II	1996-02-08
K955750	Teletom	Berchtold Holding GmbH	FQO	Class I	1996-02-08
K955740	Gluflorma	Midwest Orthodontic Mfg.	KLE	Class II	1996-02-08
K955727	Band-It 20Cc Driver/ 15 Min 20Cc Administration Set	Halyard Health	MEB	Class II	1996-02-08
K955681	Aaron 800 High Frequency Desiccator/handpiece	Geiger Instrument Co., Inc.	GEI	Class II	1996-02-08
K955654	Shortstop Disposable Prophy Angle	Spintech, Inc.	EFB	Class I	1996-02-08
K955503	Adjustable Pm Positioner	Jonathan A. Parker, D.D.S.	LQZ	Class II	1996-02-08
K955445	Caries Finder	Danville Engineering, Inc.	LFC	Class II	1996-02-08
K955428	3I Hydroxylapatite Coated Standard Threaded & Self-Tapping Implants	ZimVie US Corp LLC	DZE	Class II	1996-02-08
K955413	Endovations Triple Lumen Balloon Dilatation Catheter	Endovations	FGE	Class II	1996-02-08