Chester Labs, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Chester Labs, Inc.” (first 1985, latest 2004), across 6 product codes in 5 review panels. Median 510(k) review time under this name: 261 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | 5 | 5 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| KMJ | Lubricant, Patient | 1 | 1 |
Review panels
- Neurology (5)
- General Hospital (3)
- Physical Medicine (1)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent Chester Labs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041060 | E-Z LUBRICATING JELLY | KMJ | 2004-05-07 | 14 |
| K001705 | STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF | GYB | 2000-06-29 | 24 |
| K001593 | MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL | GEI | 2000-06-14 | 22 |
| K944599 | GRAHAM-FIELD CONDUCTIVE ECG SPRAY | GYB | 1996-05-07 | 596 |
| K944598 | GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL | GYB | 1996-05-07 | 596 |
| K944600 | GRAHAM-FIELD SALINE ELECTROLYTE GEL | GYB | 1995-11-20 | 427 |
| K944597 | GRAHAM-FIELD ULTRASOUND SCANNING GEL | IYO | 1995-06-21 | 275 |
| K944596 | GRAHAM-FIELD ULTRASOUND LOTION | IMI | 1995-06-07 | 261 |
| K940256 | BIOSHIELD BLUE LATEX GLOVES | LYY | 1994-03-23 | 61 |
| K940254 | BIOSHIELD BLUE POWDER FREE GLOVE | LYY | 1994-03-23 | 61 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Chester Labs, 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 Chester Labs, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Chester Labs, Inc.” (first 1985, latest 2004), across 6 product codes in 5 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 Chester Labs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chester Labs, Inc. is 261 days.
Which FDA product codes appear under Chester Labs, Inc.?
The most frequent FDA product codes under this applicant name are GYB (Media, Electroconductive, 5); LYY (Latex Patient Examination Glove, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 11 Chester Labs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GYB, Chester Labs, 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.