KM Products Suction Tips

Q: What is the product code of K850240?

The FDA product code is JOL – Catheter And Tip, Suction, a Class II (moderate risk) device regulated under 21 CFR 880.6740.

FDA 510(k) K850240 · Km Products

Substantially Equivalent

510(k) numberK850240

Submission

Device name: KM Products Suction Tips
Applicant: Km Products
Tucson, AZ, US
Received: January 22, 1985
Decision date: March 6, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: JOL – Catheter And Tip, Suction
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.6740
Specialty: General Hospital

Other 510(k)s with product code JOL

510(k)	Device	Applicant	Decision
K051370	Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014JOL · Traditional	Baxter Healthcare Corp	08/12/2005SE
K000266	Primary Care Solutions Sterile SALINE-0.9% Sodium Chloride for Device IrrigationJOL · Traditional	Primary Care Solutions, Inc.	07/12/2001SE
K000265	Primary Care Solutions Sterile Water Device IrrigationJOL · Traditional	Primary Care Solutions, Inc.	07/12/2001SE
K003402	Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…JOL · Traditional	Welcon, Inc.	05/01/2001SE
K994321	Sterile Water and 0.9% Sodium Chloride for Irrigation, UspJOL · Traditional	Automatic Liquid Packaging, Inc.	10/25/2000SE
K974759	Hydrox Saline Solution 0.9% Sodium Chloride 4 Oz. Cup 120 ML 100 ML BottleJOL · Traditional	Hydrox Laboratories	03/09/1998SE
K974758	Hydrox Sterile Water 4 Oz. Cup 120 Ml., Hydrox Sterile Water 100 ML BottleJOL · Traditional	Hydrox Laboratories	03/09/1998SE
K974397	Sterile Saline for Catheter CareJOL · Traditional	Baxter Healthcare Corp	02/10/1998SE
K973734	Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationJOL · Traditional	Welcon, Inc.	02/05/1998SE
K972372	Germ Trapper Suction Tube HolderJOL · Traditional	Rzv Medical Specialties, Inc.	12/11/1997SE

More from Rzv Medical Specialties, Inc.

510(k)	Device	Decision
K850105	KM Products Aspirating TubingBSY · Traditional	03/21/1985SE
K844200	K.M. Products AspiratorBTA · Traditional	01/25/1985SE

Questions and answers

When was KM Products Suction Tips cleared by the FDA?

KM Products Suction Tips (K850240) received a 510(k) decision of Substantially Equivalent on March 6, 1985, 43 days after the submission was received.

What is the product code of K850240?

The FDA product code is JOL – Catheter And Tip, Suction, a Class II (moderate risk) device regulated under 21 CFR 880.6740.