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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3513 of 3526

510(k) clearances, page 3513 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760906	Monomer Vapor Containment System	Howmedica Corp.	JDY	Class I	1976-11-11
K760903	Barrier Fabric 450 Surgical Gowns	Surgikos, Inc.	FYA	Class II	1976-11-11
K760902	Barrier Under Buttocks Drape	Surgikos, Inc.			1976-11-11
K760890	Barrier Impervious S-Ockinette	Surgikos, Inc.	KKX	Class II	1976-11-11
K760853	Stayfree Deodorant Mini-Pads	Personal Products Co.	HHL	Class II	1976-11-11
K760792	Scissor - 1.5Mm Probe Point, Angled	V. Mueller O.V. Baxter Healthcare Corp.	DWS	Class I	1976-11-11
K760791	Cooley Angled Scissor - 1Mm Probe Point	V. Mueller O.V. Baxter Healthcare Corp.	DWS	Class I	1976-11-11
K760757	Model 100 Cardiac Pacemaker	Pacesetter Systems	DXY	Class III	1976-11-11
K760582	Ha/3 Hematology Analyzer	BD Becton Dickinson Vacutainer Systems Preanalytic	GKL	Class II	1976-11-11
K760947	Pregelled Disposable Electrode	Texas Instruments, Inc.	GXY	Class II	1976-11-09
K760938	Disposable Humidifier	Travenol Laboratories, S.A.	BTT	Class II	1976-11-09
K760930	Blood Pressure & Pulse Checker	Bio Mega Diagnostic, Inc.	DXN	Class II	1976-11-09
K760926	Electrocardiograph (Model Vs-4B)	Cambridge Instruments, Inc.	DPS	Class II	1976-11-09
K760920	Cat-a-Kit	The Upjohn Co.	CHT	Class I	1976-11-09
K760899	Sterile Disposable Cotton Plugged Ser.	BD Becton Dickinson Vacutainer Systems Preanalytic	GJW	Class I	1976-11-09
K760881	Febrile Antigen Control Sera	BD Becton Dickinson Vacutainer Systems Preanalytic	GSZ	Class I	1976-11-09
K760736	Barimex, Barium Sulfate Compound	C.R. Bard Inc	KTA	Unclassified	1976-11-09
K760581	Ha/5 Hematology Analyzer	BD Becton Dickinson Vacutainer Systems Preanalytic	GKL	Class II	1976-11-09
K760356	Dish, Sterile Disposable Polystyrene	Gibco Laboratories Life Technologies, Inc.			1976-11-09
K760885	Ketotrol-E	Sigma Chemical Co.	JJX	Class I	1976-11-05
K760818	Tris Bicarbonate Diluent	Hyland Therapeutic Div., Travenol Laboratories	JJY	Class I	1976-11-05
K760808	Pho. Trax Model 4000 Whole Body Scan.	G.D. Searle and Co.	JAK	Class II	1976-11-05
K760415	Enzymatic Amylase Reagent Kit	Beckman Instruments, Inc.	CIJ	Class II	1976-11-05
K760414	Enzymatic Bun Reagent Kit	Beckman Instruments, Inc.	CDQ	Class II	1976-11-05
K760887	Compression Adjustrette	Qualitone	ESD	Class I	1976-11-03
K760867	Sterile Stockinette	Abco Dealers, Inc.	KKX	Class II	1976-11-03
K760865	Barrier Fashion Bonnet	Surgikos, Inc.	FXY	Class II	1976-11-03
K760864	Barrier Fabric 450 Specialty Gown	Surgikos, Inc.	FYA	Class II	1976-11-03
K760861	Surgical Corp.	Surgikos, Inc.	FYF	Class I	1976-11-03
K760855	Barrier Surgical Hood	Surgikos, Inc.	FXY	Class II	1976-11-03
K760850	Parkes Hump Gauge Straight 7 (18 Cm)	V. Mueller O.V. Baxter Healthcare Corp.	GDH	Class I	1976-11-03
K760814	Heparinized Penrose Tubing	Sherwood Medical Industries	GCX	Class II	1976-11-03
K760813	Heparinized Saratoga Sump Drain	Sherwood Medical Industries	GCX	Class II	1976-11-03
K760812	Heparinized Wound Suction Tubing	Sherwood Medical Industries	GCX	Class II	1976-11-03
K760811	Glove, Surgeon	Sherwood Medical Industries	KGO	Class I	1976-11-03
K760807	Barrier General Surgery Pack	Surgikos, Inc.	KKX	Class II	1976-11-03
K760778	T-Tube Drain, Round	Heyer Schulte Corp.	GCY	Class I	1976-11-03
K760772	Disposable Abdominal Binder	Tecnol New Jersey Wound Care, Inc.	FSD	Class I	1976-11-03
K760742	Cs-76 And/or Cryocare I	Frigitronics of Connecticut, Inc.	GEH	Class II	1976-11-03
K760734	Regular and Wide Skin Staples	Ethicon, Inc	GDT	Class I	1976-11-03
K760733	Skin Staple Extractor	Ethicon, Inc	GAG	Class II	1976-11-03
K760732	Skin Stapling Instrument	Ethicon, Inc	GAG	Class II	1976-11-03
K760872	Phototherapy Light	Air-Shields, Inc.	LBI	Class II	1976-11-02
K760871	Lancer Mb/cpk Isoenzyme Kit	Sherwood Medical Industries	JHY	Class II	1976-11-02
K760863	Product #K3002 Ketotrol-N(urine Control)	Sigma Chemical Co.	JJW	Class I	1976-11-02
K760862	Procedure No. 710-Ep for Alk.phos.	Sigma Chemical Co.	CIN	Class II	1976-11-02
K760849	Feldstein Blepharostomy Clip Square	V. Mueller O.V. Baxter Healthcare Corp.	HNC	Class I	1976-11-02
K760848	Feldstein Blepharoplasty Clip Rectangu	V. Mueller O.V. Baxter Healthcare Corp.	HNC	Class I	1976-11-02
K760847	Feldstein Blepharoplasty Clip Sharp P	V. Mueller O.V. Baxter Healthcare Corp.	HNC	Class I	1976-11-02
K760779	Barner Shoe Covers & Coverboots	Surgikos, Inc.	FXP	Class I	1976-11-02