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 2026-10-29, 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 2686 of 3530

510(k) clearances, page 2686 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884473	Rubin Bone Planer W/replaceable Blade	Neo Contemporary Co.	GAC	Class I	1988-12-09
K884456	Sterile Disposable Endocular Probe	Biophysic Medical, Inc.	GEX	Class II	1988-12-09
K884432	Modified Lsf Total Hip System	Implant Technology, Inc.	JDI	Class II	1988-12-09
K884430	Serum Hcg Microassay	Diamedix Corp.	DHA	Class II	1988-12-09
K884417	Surgeon's Glove Accessory	Allied Signal, Inc.	LYY	Class I	1988-12-09
K884227	Calibrator Standard Kit for Astra System	A-Kem, Inc.	JIX	Class II	1988-12-09
K884226	Amylase Reagent Kit for Astra Systems	A-Kem, Inc.	CJA	Class II	1988-12-09
K884225	Total Protein Reagent Kit for Astra Systems	A-Kem, Inc.	CEK	Class II	1988-12-09
K884013	Roche Reagent for Chloride	Roche Diagnostic Systems, Inc.	CHJ	Class II	1988-12-09
K883839	Nd:yag Laser Spectacles, Mst Model #Yls-5	Marlo Surgical Technology	KYP	Class I	1988-12-09
K883817	Accuchek II Freedom(tm) Monitoring System	Boehringer Mannheim Corp.	CGA	Class II	1988-12-09
K883470	Ids-1600 Sample Handling System	Baxter Healthcare Corporation	JQW	Class I	1988-12-09
K884523	Martin-Champy Titan Set	Buschmann Surgical Products	JEY	Class II	1988-12-08
K884394	Pacing Leads Focus T81,t81f,t82f,t83,t83f,t84f	Ela Medical, Inc.	DTB	Class III	1988-12-08
K884365	Multiflow(tm) 60 Kit	Hospal Medical Corp.	KDI	Class II	1988-12-08
K884353	Ultrx(tm) 850 Artificial Kidney	Cd Medical, Inc.	KDI	Class II	1988-12-08
K884309	Nh Pediatric Replacement Gastrostomy Kit	Biosearch Medical Products, Inc.	KNT	Class II	1988-12-08
K884291	Cook Hysterocath(tm)	Cook Inc.	KNA	Class II	1988-12-08
K884290	Baxter Disposable Circumcision Tray	Baxter Healthcare Corporation	HFX	Class II	1988-12-08
K884243	Blood Tubing Set	Mediflex Intl.	FJK	Class II	1988-12-08
K884214	Crystar(tm) Vintage Porcelain	Shofu Dental Corp.	ELL	Class II	1988-12-08
K884128	Lake N/g Extension Set	Lake Medical Products, Inc.	KNT	Class II	1988-12-08
K883922	Techmedica I.b.o. Blade	Techmedica, Inc.	DZJ	Class II	1988-12-08
K883825	Modified Sanders Bi-Papeasy	Respironics, Inc.	BYE	Class II	1988-12-08
K883592	Impra Dual Lumen Subclavian - Femoral Catheter	Impra, Inc.	LFJ	Class II	1988-12-08
K883413	Trojan Extra Strength Lubricated	Carter Products	HIS	Class II	1988-12-08
K883093	Transendoscopic Aspiration Needle	Endovations	FBK	Class II	1988-12-08
K882878	Odor-End Emergency Clean Up Powder	Cdc Products Corp.	EXB	Class I	1988-12-08
K882531	Modified L.j.'s Sex Helper	L.J. Fant & Co.	LKY	Class II	1988-12-08
K882526	Delivery Pump for Sterile Irrigant & Handpiece Dr.	Aseptico, Inc.	EIA	Class I	1988-12-08
K881476	Preemicare Model D1-X1, Series 3000	Preemicare Corp.	FMZ	Class II	1988-12-08
K881454	Retractable Needle 3Cc Syringe	Kenmar Medical	FMF	Class II	1988-12-08
K880799	Modified Ideia Chlamydia Test	Boots-Celltech Diagnostics, Inc.	LJC	Class I	1988-12-08
K884839	Modified Saw Blades to the Sagital Saw	Dyonics, Inc.	KIJ	Class I	1988-12-07
K884835	Tassi Mk2	Therapy Air Support Systems, Inc.	INX	Class II	1988-12-07
K884137	Mirage Bond	Chameleon Dental Products, Inc.	KLE	Class II	1988-12-07
K884038	Fiberlite, Fiberlite Hs and Fiberseal	Jeneric/Pentron, Inc.	EBF	Class II	1988-12-07
K883904	Apollo Vs, Vt, Vr 1000/1500, Freedom Hs, Ht, Hr	Apollo Dental Products, Inc.	EIA	Class I	1988-12-07
K883169	Otometer Portable Screening Audiometer	Otometer, Inc.	EWO	Class II	1988-12-07
K884836	Universal Generator Irrigator Model Ugi-3000	Meditron Devices, Inc.	GEI	Class II	1988-12-06
K884687	Ciba Corning Magic Lite Fsh Immunoassay	Ciba Corning Diagnostics Corp.	CGJ	Class I	1988-12-06
K884597	Beckman Lambda Light Chain Reagent	Beckman Instruments, Inc.	DFH	Class II	1988-12-06
K884596	Abbott a-Gent Lipase Reagent	Abbott Medical	CHI	Class I	1988-12-06
K883097	Gv3000 Phacoemulsifier/fragmenter	D.O.R.C. Intl. B.V.	HQC	Class II	1988-12-06
K884761	Modified Cell-Matics Herpes Simplex Virus Detect.	Difco Laboratories, Inc.	GQN	Class II	1988-12-05
K884743	Temporomandibular Joint Coil (Tmj)	Diasonics, Inc.	LNH	Class II	1988-12-05
K884606	Mt/s (Spine Transmit Coil)	Diasonics, Inc.	LNH	Class II	1988-12-05
K884475	Chelon-Fil	Espe GmbH (US)	EMA	Class II	1988-12-05
K884445	Maxithins Panty Shields, Deodorant	Tambrands Inc.	HHL	Class II	1988-12-05
K884444	Maxithins Regular Pads, Deodorant	Tambrands Inc.	HHL	Class II	1988-12-05