The Kendall Company: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “The Kendall Company” (first 2001, latest 2006), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 101 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Cardinal Health, based on public ownership records.
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 |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 | 1 |
| NGT | Saline, Vascular Access Flush | 1 | 1 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 1 | 1 |
Review panels
Most recent The Kendall Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061936 | KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 | LJS | 2006-08-09 | 30 |
| K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR | MPB | 2003-05-13 | 112 |
| K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | NIE | 2002-04-10 | 90 |
| K011283 | MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE | NGT | 2001-10-15 | 171 |
| K011941 | EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 | FRO | 2001-08-22 | 62 |
| K002902 | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS | MSD | 2001-04-09 | 203 |
| K002901 | KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER | MSD | 2001-03-28 | 191 |
| K003313 | FILAC FAS TEMP ELECTRONIC THERMOMETER | FLL | 2001-01-11 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named The Kendall Company.
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 The Kendall Company?
FDA lists 8 510(k) clearances under the applicant name “The Kendall Company” (first 2001, latest 2006), across 7 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 The Kendall Company?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Kendall Company is 101 days.
Which FDA product codes appear under The Kendall Company?
The most frequent FDA product codes under this applicant name are MSD (Catheter, Hemodialysis, Implanted, 2); FLL (Continuous Measurement Thermometer, 1); FRO (Dressing, Wound, Drug, 1).
Next steps
- See all 8 The Kendall Company clearances with predicates and recalls
- Run predicate analysis for product code MSD, The Kendall Company'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.