The Kendal Co.: FDA filings under this applicant name
FDA lists 63 510(k) clearances under the applicant name “The Kendal Co.” (first 1980, latest 2000), across 40 product codes in 8 review panels. Median 510(k) review time under this name: 57 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 |
|---|---|---|---|
| KOD | Catheter, Urological | 7 | 7 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 6 | 6 |
| CAZ | Anesthesia Conduction Kit | 3 | 3 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| DYB | Introducer, Catheter | 2 | 2 |
| EZL | Catheter, Retention Type, Balloon | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| GBM | Catheter, Urethral | 2 | 2 |
| IMD | Pack, Hot Or Cold, Disposable | 2 | 2 |
| JOW | Sleeve, Limb, Compressible | 2 | 2 |
Plus 30 more product codes.
Review panels
- Gastroenterology and Urology (26)
- Anesthesiology (10)
- General and Plastic Surgery (8)
- Cardiovascular (7)
- General Hospital (7)
- Physical Medicine (3)
- Clinical Chemistry (1)
- Orthopedic (1)
Most recent The Kendal Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000087 | MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR | FOZ | 2000-03-17 | 65 |
| K990500 | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C | EZL | 1999-09-28 | 223 |
| K991758 | MONOJECT INSULIN SYRINGE | FMF | 1999-06-14 | 21 |
| K970969 | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET | KOB | 1997-04-23 | 37 |
| K951488 | KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP | KNY | 1995-04-25 | 25 |
| K942664 | KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM | JOW | 1995-01-17 | 225 |
| K942774 | POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING | MGP | 1994-07-20 | 37 |
| K892434 | KENDALL CURITY OXYGEN MASK | BYG | 1989-08-15 | 127 |
| K892440 | KENDALL CURITY EXTENSION TUBES | FPA | 1989-07-24 | 105 |
| K892438 | KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES | FPA | 1989-07-24 | 105 |
53 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Kendal Co..
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 Kendal Co.?
FDA lists 63 510(k) clearances under the applicant name “The Kendal Co.” (first 1980, latest 2000), across 40 product codes in 8 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 Kendal Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Kendal Co. is 57 days.
Which FDA product codes appear under The Kendal Co.?
The most frequent FDA product codes under this applicant name are KOD (Catheter, Urological, 7); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 6); CAZ (Anesthesia Conduction Kit, 3).
Next steps
- See all 63 The Kendal Co. clearances with predicates and recalls
- Run predicate analysis for product code KOD, The Kendal Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.