Katecho LLC
Des Moines, IA, US
KATECHO LLC appears in FDA device records in Des Moines, IA. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Katecho LLC between 1984 and 2001. The busiest year on record is 1992, with 5. The most recent is 2001, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 5 |
| 1993 | 2 |
| 1994 | 3 |
| 1995 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 4 |
| 2001 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012404 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 | DRO | Substantially Equivalent | |
| K010543 | KM-30 TENS ELECTRODE | GXY | Substantially Equivalent | |
| K003228 | K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A | MKJ | Substantially Equivalent | |
| K002806 | K-DEFIB/PACE, MODEL KDP-60A | MKJ | Substantially Equivalent | |
| K000870 | KM-10 TENS ELECTRODE | GXY | Substantially Equivalent | |
| K993745 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 | MKJ | Substantially Equivalent | |
| K991007 | K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 | MKJ | Substantially Equivalent | |
| K981737 | K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 | MKJ | Substantially Equivalent | |
| K954504 | K-DEFIB/PACE PEDIATRIC ELECTRODE | MKJ | Substantially Equivalent | |
| K934692 | K-DEFIB/PACE PEDIATRIC ELECTRODE | MKJ | Substantially Equivalent | |
| K940801 | K-KLIP | DRX | Substantially Equivalent | |
| K935083 | PEDIATRIC DEFIB K-PADS | LDD | Substantially Equivalent - Subject to Tracking Reg. | |
| K940586 | K-SNAP | DRX | Substantially Equivalent | |
| K922202 | K-STIM CLEAR | GZJ | Substantially Equivalent | |
| K926175 | K-DEFIB/PACE CARBON ELECTRODE | DRO | Substantially Equivalent | |
| K921679 | K-DISPERSE | GZJ | Substantially Equivalent | |
| K915328 | GEL-TAC | DRO | Substantially Equivalent | |
| K914955 | K-DEFIB/PACE ELECTRODE | DRO | Substantially Equivalent | |
| K913031 | K-STIM | GXY | Substantially Equivalent | |
| K912381 | LOW BACK STRIP (OR) K-BACK | GZJ | Substantially Equivalent | |
| K912587 | K-FREE | LDD | Substantially Equivalent | |
| K900997 | K-STERILE TENS ELECTRODES | GXY | Substantially Equivalent | |
| K895662 | DEFIB K-PADS | LDD | Substantially Equivalent | |
| K863899 | K-STIK DEFIBRILLATION PADS | LDD | Substantially Equivalent | |
| K843829 | K-MESH | Substantially Equivalent | ||
| K843557 | K-APATITE 20-40 MESH K-APATITE 40-60 | ELE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1930027 | 1930027 | KATECHO LLC | 4020 GANNETT AVENUE., DES MOINES, IA 50321 US | 2026 | and 24 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QVEAdjunctive Pain Measurement Device For Anesthesiology
- LIXAid, Cardiopulmonary Resuscitation
- MKJAutomated External Defibrillators (Non-Wearable)
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- DQKComputer, Diagnostic, Programmable
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DSIDetector And Alarm, Arrhythmia
- HCCDevice, Biofeedback
- LELDevice, Sleep Assessment
- NADDressing, Wound, Occlusive
- DPSElectrocardiograph
- GXYElectrode, Cutaneous
- DRXElectrode, Electrocardiograph
- MLNElectrode, Electrocardiograph, Multi-Function
- IKNElectromyograph, Diagnostic
- ISDExerciser, Measuring
- ELEImplant, Subperiosteal
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- NSAOver-The-Counter Automated External Defibrillator
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- EWEProtector, Hearing (Circumaural)
- OMCReduced- Montage Standard Electroencephalograph
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- CCXSupport, Patient Position
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HGMSystem, Monitoring, Perinatal
- SCNTemporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
- ITXTransducer, Ultrasonic, Diagnostic
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- LBIUnit, Neonatal Phototherapy
- OSPUterine Electromyographic Monitor
- MVKWearable Automated External Defibrillator
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain