Kendall Research Center: FDA clearances and approvals
Kendall Research Center has 14 FDA 510(k) clearances (first 1976, latest 1980), across 11 product codes in 6 review panels. Median 510(k) review time: 26 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | 3 | 3 |
| CAZ | Anesthesia Conduction Kit | 2 | 2 |
| EZL | Catheter, Retention Type, Balloon | 1 | 1 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | 1 | 1 |
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | 1 | 1 |
| FQM | Bandage, Elastic | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| ITG | Bandage, Cast | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (5)
- Gastroenterology and Urology (4)
- Anesthesiology (2)
- Cardiovascular (1)
- General Hospital (1)
- Physical Medicine (1)
Most recent Kendall Research Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802225 | TENDER-SORB DRAIN SPONGES | NAB | 1980-09-26 | 14 |
| K781357 | T.E.D. SEQUENTIAL COMPRESSION SLEEVES | JOW | 1978-09-20 | 43 |
| K780408 | MICRONET LIGHT DRESSING SPONGE | NAB | 1978-03-22 | 9 |
| K780062 | CATHETER/HEMOSTATIC/GERIATRIC | EZL | 1978-02-14 | 33 |
| K780120 | ANESTHESIA TRAY, CAUDAL | CAZ | 1978-02-06 | 14 |
| K772134 | SYRINGE, IRRIGATION, PRE-FILLED | KOA | 1977-11-28 | 14 |
| K772133 | URINE SPECIMEN COLLECTING DEVICE | FCN | 1977-11-28 | 14 |
| K771655 | CURITY PEAKOMETER | FFG | 1977-10-14 | 46 |
| K771079 | CURITY IRRIGATION TRAY | GBX | 1977-09-15 | 92 |
| K771563 | CONFORM ELASTIC NETTING | FQM | 1977-09-12 | 28 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kendall Research Center.
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 Research Center have?
Kendall Research Center has 14 FDA 510(k) clearances (first 1976, latest 1980), across 11 product codes in 6 review panels.
How long does FDA take to clear Kendall Research Center's 510(k)s?
The median time from FDA receipt to decision across Kendall Research Center's cleared 510(k)s is 26 days.
What devices does Kendall Research Center make?
Its most frequent FDA product codes are NAB (Gauze / Sponge,Nonresorbable For External Use, 3); CAZ (Anesthesia Conduction Kit, 2); EZL (Catheter, Retention Type, Balloon, 1).
Has Kendall Research Center had device recalls?
openFDA lists no recalls under a recalling firm name matching Kendall Research Center. Related entities may recall under other names.
Next steps
- See all 14 Kendall Research Center clearances with predicates and recalls
- Run predicate analysis for product code NAB, Kendall Research Center'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.