Geon Corporation: FDA filings under this applicant name
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Geon Corporation” (first 1996, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 127 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 | 1 | 380 |
| 2024 | 0 | — |
| 2025 | 1 | 127 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Geon Corporation took a median 254 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 192 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 | 2 |
Review panels
Most recent Geon Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243138 | Geon (S2) Nasal Aspirator | BTA | 2025-02-04 | 127 |
| K220126 | Geonic Nasal Aspirator, Geonic Nasal Cleaner | BTA | 2023-02-02 | 380 |
| K100563 | GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA | FLL | 2010-06-02 | 93 |
| K003223 | GEON DIGITAL CLINICAL THERMOMETER | FLL | 2001-01-12 | 88 |
| K952001 | GEON ELECTRONIC THERMOMETER | FLL | 1996-10-18 | 539 |
Recalls
openFDA lists no recalls under a recalling firm named Geon Corporation.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Geon Corporation (3)
- Geon Corp. (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Geon Corporation?
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Geon Corporation” (first 1996, latest 2025), across 2 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 Geon Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Geon Corporation is 127 days.
Which FDA product codes appear under Geon Corporation?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 3); BTA (Pump, Portable, Aspiration (Manual Or Powered), 2).
Next steps
- See all 5 Geon Corporation clearances with predicates and recalls
- Run predicate analysis for product code FLL, Geon Corporation'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.