Chalgren Enterprises, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Chalgren Enterprises, Inc.” (first 1989, latest 1999), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 164 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 |
|---|---|---|---|
| IKT | Electrode, Needle, Diagnostic Electromyograph | 9 | 9 |
| GXY | Electrode, Cutaneous | 8 | 8 |
| JXE | Device, Nerve Conduction Velocity Measurement | 2 | 2 |
| GXZ | Electrode, Needle | 1 | 1 |
| HLT | Preamplifier, Ac-Powered, Ophthalmic | 1 | 1 |
Review panels
- Neurology (20)
- Ophthalmic (1)
Most recent Chalgren Enterprises, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982950 | FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 | IKT | 1999-06-22 | 305 |
| K960591 | RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP | IKT | 1996-06-13 | 122 |
| K955335 | DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE | IKT | 1996-01-29 | 70 |
| K953361 | EMG DISC RECORDING ELECTRODE | GXY | 1996-01-22 | 189 |
| K953356 | EMG RECORDING RING ELECTRODE | GXY | 1996-01-22 | 189 |
| K953354 | EMG DISC RECORDING ELECTRODE | GXY | 1996-01-22 | 189 |
| K952908 | EMG DISC RECORDING ELECTRODE WITH PIN | GXY | 1995-12-06 | 166 |
| K952690 | EMG DISC RECORDING ELECTRODE WITH PIN | GXY | 1995-12-06 | 177 |
| K953887 | RE-USABLE CONCENTRIC NEEDLE | IKT | 1995-10-31 | 75 |
| K953886 | RE-USABLE MONOPOLAR NEEDLE | IKT | 1995-10-31 | 75 |
11 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-04-12.
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 Chalgren Enterprises, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Chalgren Enterprises, Inc.” (first 1989, latest 1999), across 5 product codes in 2 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 Chalgren Enterprises, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chalgren Enterprises, Inc. is 164 days.
Which FDA product codes appear under Chalgren Enterprises, Inc.?
The most frequent FDA product codes under this applicant name are IKT (Electrode, Needle, Diagnostic Electromyograph, 9); GXY (Electrode, Cutaneous, 8); JXE (Device, Nerve Conduction Velocity Measurement, 2).
Next steps
- See all 21 Chalgren Enterprises, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IKT, Chalgren Enterprises, 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.