Kendall Healthcare Products Co. Div.Of Tyco Health: FDA filings under this applicant name
FDA lists 66 510(k) clearances under the applicant name “Kendall Healthcare Products Co. Div.Of Tyco Health” (first 1989, latest 1997), across 34 product codes in 6 review panels. Median 510(k) review time under this name: 81 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | 9 | 9 |
| KMF | Bandage, Liquid | 9 | 9 |
| JOW | Sleeve, Limb, Compressible | 4 | 4 |
| EFQ | Gauze/Sponge, Internal | 3 | 3 |
| FRO | Dressing, Wound, Drug | 3 | 3 |
| GBX | Catheter, Irrigation | 3 | 3 |
| KOD | Catheter, Urological | 3 | 3 |
| BSO | Catheter, Conduction, Anesthetic | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 | 2 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 2 | 2 |
Plus 24 more product codes.
Review panels
- General and Plastic Surgery (24)
- Anesthesiology (16)
- Gastroenterology and Urology (13)
- Cardiovascular (6)
- General Hospital (6)
- Physical Medicine (1)
Most recent Kendall Healthcare Products Co. Div.Of Tyco Health 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973763 | KENDALL CURITY IODOFORM PACKING STRIP | EFQ | 1997-12-31 | 90 |
| K973511 | KENDALL CURITY PETROLATUM GAUZE | FRO | 1997-12-16 | 90 |
| K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) | FRO | 1997-12-15 | 90 |
| K973619 | KENDALL CURITY NON-ADHERING DRESSING | KMF | 1997-12-10 | 78 |
| K973509 | KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING | KMF | 1997-12-04 | 79 |
| K973546 | KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER | EZD | 1997-11-07 | 50 |
| K970266 | KENDALL HYDROPHILIC POWDER WOUND DRESSING | KGN | 1997-04-23 | 90 |
| K963446 | KENDALL DUAL LUMEN CATHETER | MPB | 1997-03-18 | 196 |
| K964899 | KENDALL CURITY URETERAL CATHETER | EYB | 1997-02-07 | 66 |
| K964519 | CURITY THORACENTESIS TRAY | GCX | 1996-12-20 | 38 |
56 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kendall Healthcare Products Co. Div.Of Tyco Health.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kendall Research Center (14 510(k)s)
- Kendall Mcgaw Laboratories, Inc. (13 510(k)s)
- Kendall (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kendall Healthcare Products Co. Div.Of Tyco Health?
FDA lists 66 510(k) clearances under the applicant name “Kendall Healthcare Products Co. Div.Of Tyco Health” (first 1989, latest 1997), across 34 product codes in 6 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 Kendall Healthcare Products Co. Div.Of Tyco Health?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kendall Healthcare Products Co. Div.Of Tyco Health is 81 days.
Which FDA product codes appear under Kendall Healthcare Products Co. Div.Of Tyco Health?
The most frequent FDA product codes under this applicant name are CAZ (Anesthesia Conduction Kit, 9); KMF (Bandage, Liquid, 9); JOW (Sleeve, Limb, Compressible, 4).
Next steps
- See all 66 Kendall Healthcare Products Co. Div.Of Tyco Health clearances with predicates and recalls
- Run predicate analysis for product code CAZ, Kendall Healthcare Products Co. Div.Of Tyco Health'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.