Kendall: FDA clearances and approvals
Kendall has 12 FDA 510(k) clearances (first 2004, latest 2009), across 5 product codes in 2 review panels. Median 510(k) review time: 71 days.
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 | 7 | 7 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
| NFK | Kit, Repair, Catheter, Hemodialysis | 1 | 1 |
Review panels
Most recent Kendall 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT | NFK | 2009-11-19 | 69 |
| K062671 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) | MSD | 2006-11-03 | 56 |
| K060972 | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) | MSD | 2006-08-04 | 119 |
| K053410 | GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR | FEG | 2006-01-06 | 30 |
| K051584 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY | MSD | 2005-10-06 | 113 |
| K043272 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP | MSD | 2004-12-22 | 26 |
| K042461 | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 | LJS | 2004-12-10 | 91 |
| K042572 | KENDALL CO2NFIRM NOW CO2 DETECTOR | KNT | 2004-11-05 | 45 |
| K041914 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER | MSD | 2004-09-27 | 73 |
| K041006 | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR | MSD | 2004-05-19 | 30 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kendall.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kendall have?
Kendall has 12 FDA 510(k) clearances (first 2004, latest 2009), across 5 product codes in 2 review panels.
How long does FDA take to clear Kendall's 510(k)s?
The median time from FDA receipt to decision across Kendall's cleared 510(k)s is 71 days.
What devices does Kendall make?
Its most frequent FDA product codes are MSD (Catheter, Hemodialysis, Implanted, 7); FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation, 2); KNT (Tubes, Gastrointestinal (And Accessories), 1).
Has Kendall had device recalls?
openFDA lists no recalls under a recalling firm name matching Kendall. Related entities may recall under other names.
Next steps
- See all 12 Kendall clearances with predicates and recalls
- Run predicate analysis for product code MSD, Kendall's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.