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 3496 of 3526

510(k) clearances, page 3496 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770411	Digi Trol Tm-Rx & Digi Trol Tm-Tx	Nuclear Medical Laboratories, Inc.	DMP	Class I	1977-03-16
K770404	Obturator	Abbott Medical	DRB	Class II	1977-03-16
K770403	Catheter-Thru-Needle Device	Abbott Medical	FOZ	Class II	1977-03-16
K770370	Convenience Tray	Johannah Medical Services, Inc.	FMI	Class II	1977-03-16
K770354	Tubing, Aerosal, Disposable	Inhal-O-Tech Medical Plastic	BZO	Class I	1977-03-16
K770353	Disposable Temperature Probe	Inhal-O-Tech Medical Plastic	KPD	Class II	1977-03-16
K770320	Urinary Drainage Set, Closed, Sterile	Medical Devices Inc.	KNX	Class II	1977-03-16
K770299	Tygon M-60/Tygon M-70	Norton Performance Plastics Corp.	FID	Class II	1977-03-16
K770271	Chemstrip G	Boehringer Mannheim Corp.	JIL	Class II	1977-03-16
K770269	Cammadisk Digoxin	Burroughs Wellcome Co.	DON	Class II	1977-03-16
K770082	Salonmay Bustline Increaser	Gamma Enterprises, Inc.	MWZ	Class I	1977-03-16
K770015	Noseclip for Resp. Care & Pulmon. Func.	BD Becton Dickinson Vacutainer Systems Preanalytic	BXJ	Class I	1977-03-16
K761272	Centria T4 Ria	Clinical Diagnostics, Inc.	CDX	Class II	1977-03-16
K770448	Ins - t.e.n.s.	Stimulation Technology, Inc.	GXY	Class II	1977-03-15
K770447	Epc Insticks	Stimulation Technology, Inc.	GXY	Class II	1977-03-15
K770440	Implant, Dental, Pyrolite Carbon Endo.	General Atomic Co.	DZE	Class II	1977-03-15
K770426	Oxygen Manifold Systems, Nitrous Oxide	Bel-Med, Inc	CAM	Class I	1977-03-15
K770408	Karaya Gum Powder, Ostomy	Howmedica Corp.	EZK	Class II	1977-03-15
K770407	Shield, Dental X-Ray, Protective	Worldwide Dental, Inc.	IWO	Class I	1977-03-15
K770290	Monitoring Kit, Central Venous Pressure	Argon Medical Corp.	DQO	Class II	1977-03-15
K770182	0.22/Um Filterset W/y-Injection Site	Abbott Medical	FPB	Class II	1977-03-15
K761350	Myotron	Somatronics, Inc.	HCC	Class II	1977-03-15
K770462	Puncture Kit, Internal Jugular	Arrow Intl., Inc.	DQO	Class II	1977-03-14
K770421	Components, Ankle, Trial, Con-Axial	Depuy, Inc.	HSN	Class II	1977-03-14
K770420	Forceps, Ankle Inserting, Con-Axial	Depuy, Inc.	HSN	Class II	1977-03-14
K770389	Lens Set, Mentor Trial	Cerenovus, Inc.	HPC	Class I	1977-03-14
K770388	Fracture Reduction Sys., Model or 1001	Sisan Assoc.	JEC	Class II	1977-03-14
K770185	Rh Control Diluent	BD Becton Dickinson Vacutainer Systems Preanalytic	KSZ	Class II	1977-03-14
K770125	Dispos-a-Care Thermometer Sheath	Chesebrough-Pond'S U.S.A. Co.	FLK	Class II	1977-03-14
K770119	i.v. Lok Tm	Jelco Laboratories	KMK	Class I	1977-03-14
K770112	Specimen Collector	Abbott Medical	FMH	Class I	1977-03-14
K770441	Gar, Columbia, W/5% Horse Blood	BD Becton Dickinson Vacutainer Systems Preanalytic	JSO	Class II	1977-03-10
K770416	Lead, Heart, Butterfly Clamp	Arco Medical Products Co.	DTB	Class III	1977-03-10
K770405	Overload Warning Device	Synthes (USA) Products LLC	IRN	Class II	1977-03-10
K770402	Radioear Model 1072	Radioear Corp.			1977-03-10
K770397	Monitor, Radioisotope, Model 9273A	Amersham Corp.			1977-03-10
K770288	Spectrophotometer, Model 597 Ir	Revvity Health Sciences, Inc.	JJQ	Class I	1977-03-10
K770278	Spectrophotometers, Infrared Models X99	Revvity Health Sciences, Inc.	JJQ	Class I	1977-03-10
K770108	Tube Holding Device	Pharmaseal Div., Baxter Healthcare Corp.	FPK	Class II	1977-03-10
K760851	Converse Altar Retractor	V. Mueller O.V. Baxter Healthcare Corp.	KAL	Class I	1977-03-10
K760674	Syn-O-Scope Nasal Inhaler	Mcdonald and Assoc., Inc.	KCO	Class I	1977-03-10
K770399	Valve for Closed Sys. Urinary Drainage	Will Ross Co.	KNX	Class II	1977-03-09
K770379	Trocar Sleeve System	Richard Wolf Medical Instruments Corp.	HET	Class II	1977-03-09
K770378	Laparoscope, Fiber Light, Palmer-Jacobs	Richard Wolf Medical Instruments Corp.	HET	Class II	1977-03-09
K770305	Cutter, P607 Bone	Dentronix, Inc.	FZT	Class I	1977-03-09
K770304	Cutter, P605 General Purpose	Dentronix, Inc.	FZT	Class I	1977-03-09
K770303	Nipper, Nail, P610 English	Dentronix, Inc.	FZT	Class I	1977-03-09
K770302	Cutter, P606 Bone	Dentronix, Inc.	FZT	Class I	1977-03-09
K770297	Fetal Monitor, Part #100-11009	Brattle Instrument Corp.	HGM	Class II	1977-03-09
K770296	Fetal Monitor, Part #101-11009	Brattle Instrument Corp.	HGM	Class II	1977-03-09