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 2749 of 3530

510(k) clearances, page 2749 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880997	Spring Retractor	T. Korossurgical Instruments Corp.	GAD	Class I	1988-03-21
K880942	Repak Surgical Pack (Gown,towel,major,drape,basic)	Repack Surgical Enterprises, Inc.	LRO	Class II	1988-03-21
K880905	Mammography Moving Grid Bucky	Custom Medical Products, Ltd.	IZH	Class II	1988-03-21
K880869	Medi-Let	Medicore Co. Ltd.	FMK	Class II	1988-03-21
K880859	Surgical Burs	New England Surgical Instrument Corp.	GFF	Class I	1988-03-21
K880739	Dyonics Drill Guide/isometer System	Dyonics, Inc.	LXI	Class I	1988-03-21
K880682	Mask, Anesth. Inflatable & Pediatric Scented, Disp	King Systems Corporation.	BSJ	Class I	1988-03-21
K880636	Reticcount Software	BD Becton Dickinson Vacutainer Systems Preanalytic	GKL	Class II	1988-03-21
K880608	Msi-Pc	Medical Specialties Inc.	GJP	Class II	1988-03-21
K880565	3M Trimatic M Modular System and Accessories	3M Company	IXW	Class II	1988-03-21
K880564	3M Xp 505 X-Ray Film Processor	3M Company	IXW	Class II	1988-03-21
K880563	3M Xp515 X-Ray Film Processor	3M Company	IXW	Class II	1988-03-21
K880448	Cerion Oxy Threshold Alarm	Ceramatec, Inc.	CCL	Class II	1988-03-21
K880319	Magill Forceps	Eastmed Enterprises, Inc.	BWB	Class I	1988-03-21
K880318	Rovenstein Forceps	Eastmed Enterprises, Inc.	BWB	Class I	1988-03-21
K880162	Pleur-Evac--a-5002 Chest Drainage System W/auto	Deknatel, Inc.	CAC	Class II	1988-03-21
K875345	Vision(r) Crp	Abbott Medical	DCK	Class II	1988-03-21
K875302	Medical Eye Disposable Shield	Bfd, Inc.	HOY	Class I	1988-03-21
K875107	Health Care Eye Protection	Surgikos, Inc.	HOY	Class I	1988-03-21
K874898	Cm 3000 the Monitor	Lifeline Medical Systems, Inc.	BZQ	Class II	1988-03-21
K874754	Sara Digicap	Ppg/Applied Resources, Inc.	CCK	Class II	1988-03-21
K874193	Microshev Model 2000	Micro-Shev, Ltd.	GWJ	Class II	1988-03-21
K874157	Lase Evacuator/aspirator	Lase, Inc.	BTA	Class II	1988-03-21
K880713	Clp 0.1 M Sodium Citrate Solution	Creative Laboratory Products, Inc.	JPA	Class II	1988-03-18
K880711	Clp 0.02 M Calcium Chloride Solution.	Creative Laboratory Products, Inc.	GIT	Class II	1988-03-18
K880482	Secondary Solution Administration Set W/sheath	Baxter Healthcare Corporation	FPA	Class II	1988-03-18
K880335	Intra II Secret Ear Hearing Aids Ise	Starkey Laboratories, Inc.	ESD	Class I	1988-03-18
K880334	Custom Canal Hearing Aids Intra II Cc-5, 6 & 7	Starkey Laboratories, Inc.	ESD	Class I	1988-03-18
K880333	Custom I.t.e. Hearing Aids Ce-5, Ce-6, Ce-7	Starkey Laboratories, Inc.	ESD	Class I	1988-03-18
K875351	Den-Mat Poretch (Porcelain Etchant)	Den-Mat Corp.	ELL	Class II	1988-03-18
K875344	Heraeus' Heragam 48, Non Gamma 2 Den. Amal. Alloy	Kulzer GmbH	EJJ	Class II	1988-03-18
K875255	Dream Dam	Dental Dam, Inc.	EIE	Class I	1988-03-18
K875168	Quidel Total Ige Test	Ortho-Clinical Diagnostics, Inc.	DHB	Class II	1988-03-18
K874458	Prime Plus-Polyacrylic Acid Bond Conditioner	Lustgarten Multi-Tech International, Inc.	EMA	Class II	1988-03-18
K874308	Jel-62	Jelenko Co.	EJT	Class II	1988-03-18
K874228	Bond Fast No Mix Adhesive	Advanced Orthodontics Systems, Inc.	DYH	Class II	1988-03-18
K872712	Pc Polygraf	Synectics-Dantec	KLA	Class II	1988-03-18
K881012	Wound-Evac Rs	Heritage Medical Products, Inc	GCY	Class I	1988-03-17
K880964	Polyderm Pec(tm), Porous Elastic Cover	Laivan Corp.	KGX	Class I	1988-03-17
K880911	Blunt Sponge	Ormed Mfg., Inc.	EFQ	Unclassified	1988-03-17
K880910	Round Stick Sponges	Ormed Mfg., Inc.	EFQ	Unclassified	1988-03-17
K880909	Tracheotomy Sponges	Ormed Mfg., Inc.	EFQ	Unclassified	1988-03-17
K880907	Triangle Sponge	Ormed Mfg., Inc.	EFQ	Unclassified	1988-03-17
K880901	Sonicator 710 (Model Me710)	Mettler Electronics Corp	IMI	Class II	1988-03-17
K880874	Immunoadsorbed Factor VII Deficient Plasma Human	Baxter Healthcare Corporation	GJT	Class II	1988-03-17
K880861	Mechanical Adjustable Chair (Ac Powered)	Craftmatic/Contour Organization, Inc.	INO	Class II	1988-03-17
K880854	Strung Absorbent Balls	Ormed Mfg., Inc.	EFQ	Unclassified	1988-03-17
K880853	Cherry Sponge	Ormed Mfg., Inc.	EFQ	Unclassified	1988-03-17
K880852	Rosebud Dissectors	Ormed Mfg., Inc.	EFQ	Unclassified	1988-03-17
K880851	Flat Stick Sponge	Ormed Mfg., Inc.	EFQ	Unclassified	1988-03-17