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 2761 of 3530

510(k) clearances, page 2761 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873041	A-V Recorder	Life Sciences Manufacturing, Inc.	DPT	Class II	1988-02-04
K871828	Ted Model 760	Teledyne, Inc.	CCK	Class II	1988-02-04
K880271	Resubmitted Excalibur	Quinton, Inc.	ISD	Class II	1988-02-03
K880222	Zenith Traveler Chiropractic Table	Williams Manufacturing Co.	INW	Class I	1988-02-03
K875304	Biotrol Calibrant Level 2	Biotrol, USA, Inc.	JIX	Class II	1988-02-03
K875252	Aca Du Pont Urine Cannabinoids (U Thc) Screen Meth	E.I. Dupont de Nemours & Co., Inc.	LDJ	Class II	1988-02-03
K875249	Sutter Phalangeal Cap	Sutter Biomedical, Inc.	KWD	Class II	1988-02-03
K874915	Orthomet Cathcart Orthocentric Hip Prosthesis	Orthomet, Inc.	KWL	Class II	1988-02-03
K874775	Electrode Tip Cleaner	C.R. Bard Inc	GEI	Class II	1988-02-03
K871848	Nutrition Delivery Sets for Vm 05 Ambula. Pump	Panamedix, Inc.	KNT	Class II	1988-02-03
K875318	Biotrol Calibrant Level 3	Biotrol, USA, Inc.	JIX	Class II	1988-02-02
K875288	Biotrol Calibrant Level 1	Biotrol, USA, Inc.	JIX	Class II	1988-02-02
K875262	V-Trend Beta-Hcg Dry-Spot Test	Texas Immunology, Inc.	JHJ	Class II	1988-02-02
K875210	Alkaline Phosphatase Cat. # 306-22, 306-23	Diagnostic Chemicals, Ltd. (USA)	CJE	Class II	1988-02-02
K875206	Lactate Dehydrogenase Cat. # 320-68, 320-69	Diagnostic Chemicals, Ltd. (USA)	CFJ	Class II	1988-02-02
K875176	Wako(tm) Uibc	FUJIFILM Healthcare Americas Corporation	JQF	Class I	1988-02-02
K875104	Surgi-Light Disposable System for Pulmonology Use	Laserguide	LLO	Class II	1988-02-02
K874962	Forceps Cliprack Ventricular Cannula Saws Spatulas	Solway, Inc.	HAO	Class I	1988-02-02
K874939	Schurman/carter II Hip Prosthesis, Porous Coated	Kirschner Medical Corp.	DXQ	Class II	1988-02-02
K874896	Sarns Visiflow Aortic Arch Cannula	3M Health Care, Sarns	DWF	Class II	1988-02-02
K874867	Catr(tm)-H Cardiotomy Holder	Bentley Laboratories, Inc.	KPI	Class II	1988-02-02
K874841	Integrated Membrane Oxygenator W/cardiotomy Filter	Bentley Laboratories, Inc.	DTZ	Class II	1988-02-02
K874757	Stratus(r) Immunoassay Controls Levels I, II, III	Baxter Healthcare Corporation	DIF	Class I	1988-02-02
K874752	Gamow Hyperbaric Bag	Hyperbaric Aerobics, Ltd.	CBF	Class II	1988-02-02
K874692	Pulsemate Bx-5	Colin Medical Instruments Corp.	DQA	Class II	1988-02-02
K874659	Sterilization of Devices by Radiation	Inhalation Plastics, Inc.	BTT	Class II	1988-02-02
K874605	Hi-Lo Temp(r) Myocardial Temperature Sensor	Mallinckrodt Critical Care	KRI	Class I	1988-02-02
K874302	Quantimetrix Total Creatine Kinase Control	Quantimetrix Medical Industries	JJT	Class I	1988-02-02
K874205	Endocardial Screw-in Lead, Model 1018T	Pacesetter Systems	DTB	Class III	1988-02-02
K874087	Modified Calcitonin Ria Kit Dsl #1200	Diagnostic Systems Laboratories, Inc.	JKR	Class II	1988-02-02
K873986	Beta-Hcg Assay	Schiff & Co.	DHA	Class II	1988-02-02
K873962	Medtronic Model 4016A Endocardial Pacing Lead	Medtronic, Inc.	DTB	Class III	1988-02-02
K873924	Pti Heart-Chill Pouch/pad Sling (Sterile)	Buckman Co., Inc.	DWC	Class II	1988-02-02
K873892	Surgi-Light Dispos.fiberoptic Del/sys Gi/uro Use	Laserguide	LNK	Class II	1988-02-02
K873199	Ohmeda 4700 Oxicap Monitor	GE Healthcare	DQA	Class II	1988-02-02
K872843	Oveia (Tm) Dual Analyte	Boots-Celltech Diagnostics, Inc.	JLP	Class I	1988-02-02
K872709	Model 20-C, Rl-20A/u, Ob-10A/u	Directed Energy, Inc.	HHR	Class II	1988-02-02
K870841	Model 20-C W/br-20A/u Attach/model Hl-3.0 Ob/gyn	Directed Energy, Inc.	HHR	Class II	1988-02-02
K870708	Glucoscot II Blood Glucose Test System	Kyoto Daiichi Kagaku Co., Ltd.	LFR	Class II	1988-02-02
K870653	Ultrasound Linear/sector Scanner 1100	Pie Data Medical BV	KNG	Class II	1988-02-02
K870058	Pie Medical Scanner 1000	Pie Data Medical BV	KNG	Class II	1988-02-02
K875341	Edec 60 r/f	Electromed Intl., Ltd.	IZO	Class I	1988-02-01
K875320	Biotrol Uric Acid Enzymatique UV H.p.	Biotrol, USA, Inc.	CDO	Class I	1988-02-01
K875209	Acid Phosphatase (Kinetic) Cat. # 320-06	Diagnostic Chemicals, Ltd. (USA)	CKB	Class II	1988-02-01
K873566	Electrostim I.f.	Promatek Industries, Ltd.	LIH	Class II	1988-02-01
K870815	Kontron e.e.g. Monitor, Supermon Module 7265	Kontron Instruments, Inc.	GWQ	Class II	1988-02-01
K880093	Caretex Skid Resistant Shoe Covers	James River Corp.	FXP	Class I	1988-01-29
K880028	Omed Disposable Scalpel	Oxboro Medical Intl., Inc.	GDX	Class I	1988-01-29
K875342	Edec 90C	Electromed Intl., Ltd.	IZO	Class I	1988-01-29
K875292	Microdiscectomy Curette Set	T. Korossurgical Instruments Corp.	FZS	Class I	1988-01-29