Cadwell Laboratories, Inc.: FDA clearances and approvals
Cadwell Laboratories, Inc. has 46 FDA 510(k) clearances (first 1979, latest 2007), across 16 product codes in 3 review panels. Median 510(k) review time: 192 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 12 | 12 |
| GXY | Electrode, Cutaneous | 7 | 7 |
| GWQ | Full-Montage Standard Electroencephalograph | 4 | 4 |
| GXZ | Electrode, Needle | 4 | 4 |
| GYB | Media, Electroconductive | 3 | 3 |
| GWE | Stimulator, Photic, Evoked Response | 2 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | 2 | 2 |
| HLX | Photostimulator, Ac-Powered | 2 | 2 |
| IKN | Electromyograph, Diagnostic | 2 | 2 |
| LEL | Device, Sleep Assessment | 2 | 2 |
Plus 6 more product codes.
Review panels
- Neurology (41)
- Ophthalmic (3)
- Anesthesiology (2)
Most recent Cadwell Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061706 | CADWELL EASYNET OXIMETER MODULE | DQA | 2007-03-05 | 262 |
| K061705 | CADWELL EASYNET NASAL PRESSURE MODULE | MNR | 2006-11-21 | 158 |
| K042350 | TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR | GWF | 2004-11-03 | 65 |
| K040986 | CADWELL LIMB MOVEMENT MODULE | LEL | 2004-07-01 | 77 |
| K040932 | EASYNET BODY POSITION MODULE | LEL | 2004-07-01 | 83 |
| K971214 | KILOWIN | GWE | 1998-06-11 | 435 |
| K962458 | CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER | GWF | 1997-01-13 | 202 |
| K962457 | TWO-CHANNEL PREAMPLIFIER | GWF | 1997-01-13 | 202 |
| K962455 | FOUR-CHANNEL PREAMPLIFIER | GWF | 1997-01-13 | 202 |
| K946094 | CADWELL EASY AMBULATORY EEG | GWQ | 1995-09-12 | 272 |
36 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cadwell Laboratories, Inc..
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 Cadwell Laboratories, Inc. have?
Cadwell Laboratories, Inc. has 46 FDA 510(k) clearances (first 1979, latest 2007), across 16 product codes in 3 review panels.
How long does FDA take to clear Cadwell Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cadwell Laboratories, Inc.'s cleared 510(k)s is 192 days.
What devices does Cadwell Laboratories, Inc. make?
Its most frequent FDA product codes are GWF (Stimulator, Electrical, Evoked Response, 12); GXY (Electrode, Cutaneous, 7); GWQ (Full-Montage Standard Electroencephalograph, 4).
Has Cadwell Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cadwell Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 46 Cadwell Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWF, Cadwell Laboratories, Inc.'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.