Katecho, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Katecho, Inc.” (first 1984, latest 2001), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 139 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 7 | 7 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 4 | 4 |
| GXY | Electrode, Cutaneous | 4 | 4 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 4 | 4 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 3 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| ELE | Implant, Subperiosteal | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (17)
- Neurology (7)
- Dental (1)
Most recent Katecho, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012404 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 | DRO | 2001-10-12 | 74 |
| K010543 | KM-30 TENS ELECTRODE | GXY | 2001-05-23 | 89 |
| K003228 | K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A | MKJ | 2000-12-14 | 59 |
| K002806 | K-DEFIB/PACE, MODEL KDP-60A | MKJ | 2000-11-21 | 74 |
| K000870 | KM-10 TENS ELECTRODE | GXY | 2000-11-07 | 232 |
| K993745 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 | MKJ | 2000-02-03 | 90 |
| K991007 | K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 | MKJ | 1999-08-23 | 150 |
| K981737 | K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 | MKJ | 1998-12-09 | 205 |
| K954504 | K-DEFIB/PACE PEDIATRIC ELECTRODE | MKJ | 1995-11-17 | 50 |
| K934692 | K-DEFIB/PACE PEDIATRIC ELECTRODE | MKJ | 1995-01-24 | 481 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Katecho, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Katecho, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Katecho, Inc.” (first 1984, latest 2001), across 8 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Katecho, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Katecho, Inc. is 139 days.
Which FDA product codes appear under Katecho, Inc.?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 7); DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 4); GXY (Electrode, Cutaneous, 4).
Next steps
- See all 26 Katecho, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Katecho, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.