Kells Medical, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Kells Medical, Inc.” (first 1982, latest 1993), across 11 product codes in 6 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| KPE | Container, I.V. | 2 | 2 |
| BXP | Transducer, Gas Flow | 1 | 1 |
| ESE | Larynx, Artificial (Battery-Powered) | 1 | 1 |
| ETF | Unit, Examining/Treatment, Ent | 1 | 1 |
| ETY | Tester, Auditory Impedance | 1 | 1 |
| KCJ | Applicator, Ent | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| LIX | Aid, Cardiopulmonary Resuscitation | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ear, Nose and Throat (4)
- General Hospital (2)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
Most recent Kells Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926333 | CPR PLUS | LIX | 1993-11-08 | 327 |
| K890093 | PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET | KNT | 1989-07-24 | 195 |
| K890095 | PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | KPE | 1989-05-24 | 134 |
| K890094 | EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | KPE | 1989-05-24 | 134 |
| K861972 | DERMISTRIP | NAD | 1986-06-27 | 37 |
| K844463 | DERMIDRESS | KGX | 1985-01-08 | 49 |
| K844072 | DERMIZIP SKIN CLOSURE DEVICE | — | 1984-11-05 | 18 |
| K832678 | PHONATORY FUNCTION ANALYZER PS-77 | BXP | 1984-03-07 | 211 |
| K832667 | LUCAE'S EAR & NASAL APPLICATORS | KCJ | 1983-09-29 | 51 |
| K823118 | SAY | ESE | 1983-01-07 | 78 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kells Medical, Inc..
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 Kells Medical, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Kells Medical, Inc.” (first 1982, latest 1993), across 11 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 Kells Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kells Medical, Inc. is 64 days.
Which FDA product codes appear under Kells Medical, Inc.?
The most frequent FDA product codes under this applicant name are KPE (Container, I.V., 2); BXP (Transducer, Gas Flow, 1); ESE (Larynx, Artificial (Battery-Powered), 1).
Next steps
- See all 12 Kells Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPE, Kells Medical, Inc.'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.