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 2773 of 3530

510(k) clearances, page 2773 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873640	Modified Dsp100 Amplifier	Intl. Acoustics, Inc.	DQC	Class I	1987-12-07
K873632	Hi-Nek Total Hip	Mizuho Orthopedic Systems Inc	JDI	Class II	1987-12-07
K873448	Foley Catheter Temperature Sensor	Respiratory Support Products, Inc.	KOD	Class II	1987-12-07
K873343	Entube-Meer and Meer Feeding Tube Bridle System	Entech, Inc.	KNT	Class II	1987-12-07
K872715	Universal Instrumentation(cd) for Spinal Surgery	Roseburg SA	JDN	Class II	1987-12-07
K872370	Bioma 3500	E.B.S., Inc.	KRC	Class II	1987-12-07
K872359	Enviracaire Model Ev-1	Enviracaire Corp.	FRF	Class II	1987-12-07
K872033	Bio-Medicus Cannula-Tubing	Bio Medicus, Inc.	DWF	Class II	1987-12-07
K871490	Colorview 860 or Ssd-860 Pulse Echo/modification	GE Medical Systems Information Technologies, Inc.	DPW	Class II	1987-12-07
K874639	Remote-Controlled Universal Diag. Table Rs-100	Shimadzu Precision Instruments, Inc.	KXJ	Class II	1987-12-04
K874589	Bernafon Colibri, C-2H Hearing Aids	Bernafon LLC	ESD	Class I	1987-12-04
K874461	Hemo-Sol	Chem Pharm, Inc.	KEM	Class I	1987-12-04
K874178	Biotis (Tm) Bcye Selective	Otisville Biopharm, Inc.	JSJ	Class I	1987-12-04
K874177	Biotis (Tm) Bcye	Otisville Biopharm, Inc.	KZI	Class I	1987-12-04
K874175	Biotis (Tm) Mueller Hinton W/4% Salt, 6Mcg/ml Oxac	Otisville Biopharm, Inc.	JSF	Class I	1987-12-04
K874174	Biotis (Tm) Starch Hydrolysis with Bcp	Otisville Biopharm, Inc.	JSF	Class I	1987-12-04
K874161	Modified Use of Triangle Bandage Sterile	K. W. Griffen Co.	NAD	Class I	1987-12-04
K874131	Cresolphthalein Complexone, Calcium	Horiba Instruments Incorporated	CIC	Class II	1987-12-04
K874063	Enteron Abdominal Paracentesis Tray	Endovations	KDD	Class I	1987-12-04
K873960	Lewis Safe Sleeve	Cheri Lewis, D.D.S.	EIF	Class I	1987-12-04
K872810	Strung Dental Rolls	American Silk Sutures, Inc.	EFN	Class I	1987-12-04
K872726	Dgh-3000A a-Scan	DGH Technology, Inc.	IYO	Class II	1987-12-04
K872576	Colorgene DNA Hybridization Test Cmv Confirmation	Enzo Biochem, Inc.	GQH	Class II	1987-12-04
K874517	Pharmaseal Rubber Urethral Catheter	American Pharmaseal Div. Ahsc	KOD	Class II	1987-12-03
K874410	Cumevac	Cumes-Honikman Partnership	FFD	Class I	1987-12-03
K874104	Ohmeda Biox 3760 Pulse Oximeter	GE Healthcare	DQA	Class II	1987-12-03
K874097	Stachrom Viii:c Test Kit	American Bioproducts Co.	GGP	Class II	1987-12-03
K874045	Pharmaseal Endoscopy Prep Kit Upper and Lower	American Pharmaseal Div. Ahsc	NWU	Class II	1987-12-03
K873929	'Catch-It' or Fecal Containment Device	Midwest Medical Co.	EXB	Class I	1987-12-03
K873921	Model 366-30 Adaptaid(tm) Adapter Sleeve	Intermedics, Inc.	DTB	Class III	1987-12-03
K873776	Ivac(r) Star-Flow(tm) Volumetric Pump - Model 580+	Y	FRN	Class II	1987-12-03
K873698	Sterilized Dental Bit Packaging	Florida Diamond Instruments Corp.	EJL	Class I	1987-12-03
K873672	Model 1010 Physiological Signal Telemetry Monitor	Novametrix Medical Systems, Inc.	DRG	Class II	1987-12-03
K873543	Stubbie Steerable Guidewire	Target Therapeutics	DQX	Class II	1987-12-03
K873485	Edslab (R) Occlusion Balloon Catheter	American Edwards Laboratories	DQY	Class II	1987-12-03
K873165	Chemo-Port Non-Coring Needles	Hdc Corp.	FMI	Class II	1987-12-03
K872972	Temporary Pacemaker Electrode	Oscor Medical Corp.	LDF	Class II	1987-12-03
K872921	Mss Enteral Delivery Set	Medical Support, Inc.	KNT	Class II	1987-12-03
K871796	Numed Pta Catheters	Numed Inc	LIT	Class II	1987-12-03
K870700	Micro-Guide	Catheter Research C/O Burditt, Bowles & Radzius	DQO	Class II	1987-12-03
K874645	Closed Wound Drainage Systems	Hall Laboratories, Inc.	GCY	Class I	1987-12-02
K874634	Nsn #6515-00-333-2400 Adson Dressing Forceps	I-Tech Industries SRL	GEN	Class I	1987-12-02
K874608	Tecnol Fluid Shield Surgical Mask	Tecnol New Jersey Wound Care, Inc.	FXX	Class II	1987-12-02
K874596	Perforated Soaking Tube	Specialty Medical Products Co.	GBQ	Class I	1987-12-02
K874585	Angiomed Osty-Cut Bone Biopsy Needle	Angiomed U.S., Inc.	DWO	Class I	1987-12-02
K874572	Allegro (Tm) Ferritin Immunoassay System	Nichols Institute Diagnostics	DBF	Class II	1987-12-02
K874503	Micro-Aire Osteotome System or Bone Harvester	Micro-Aire Surgical Instruments, Inc.	HWM	Class I	1987-12-02
K874428	Auto Suture Purse String Applier*	United States Surgical, A Division of Tyco Healthc	GDJ	Class I	1987-12-02
K874426	New Antimicro. Agents:augmentin,aztreonam,ciproflo	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1987-12-02
K874318	Maximum Control Gown	Ulti-Med Intl., Inc.	FYC	Class II	1987-12-02