K-Free

FDA 510(k) K912587 · Katecho, Inc.

Substantially Equivalent

510(k) numberK912587

Submission

Device name
K-Free
Applicant
Katecho, Inc.
Des Moines, IA, US
Received
June 12, 1991
Decision date
July 30, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5300
Specialty
Cardiovascular
Life-sustaining
Yes

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K103651CardiomedLDD · Traditional Cardio Medical Products, Inc.10/04/2011SE
K103783Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads PediatricLDD · Traditional Fiab Spa06/16/2011SE
K103334Cardio MedLDD · Traditional Cardio Medical Products, Inc.01/18/2011SE
K103159Cardio Med Model A102, H104, O101, P103, and Z100LDD · Traditional Cardio Medical Products, Inc.01/11/2011SE
K102468Zoll Propaq MDLDD · Special Zoll Medical Corporation, World Wide Headquarters09/30/2010SE

More from Zoll Medical Corporation, World Wide Headquarters

510(k)DeviceDecision
K012404K-Defib/Pace Adult Electrode, Model KDP-85DRO · Traditional 10/12/2001SE
K010543KM-30 TENS ElectrodeGXY · Traditional 05/23/2001SE
K003228K-Defib/Pace Multifuction Pediatric Electrode, Model KDP-70AMKJ · Traditional 12/14/2000SE
K002806K-Defib/Pace, Model KDP-60AMKJ · Traditional 11/21/2000SE
K000870KM-10 TENS ElectrodeGXY · Traditional 11/07/2000SE
K993745K-Defib/Pace Adult Electrode, Model KDP-80MKJ · Traditional 02/03/2000SE
K991007K-Defib/Pace Radiolucent Adult Electrode, Model KRT-60MKJ · Traditional 08/23/1999SE
K981737K-Defib/Pace Adult Electrode Model Number KDP-60MKJ · Traditional 12/09/1998SE
K954504K-Defib/Pace Pediatric ElectrodeMKJ · Traditional 11/17/1995SE
K934692K-Defib/Pace Pediatric ElectrodeMKJ · Traditional 01/24/1995SE

Questions and answers

When was K-Free cleared by the FDA?

K-Free (K912587) received a 510(k) decision of Substantially Equivalent on July 30, 1991, 48 days after the submission was received.

What is the product code of K912587?

The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.