Louis M. Gerson Co., Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Louis M. Gerson Co., Inc.” (first 1980, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 124 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 |
|---|---|---|---|
| FXX | Mask, Surgical | 4 | 4 |
| MSH | Respirator, Surgical | 3 | 3 |
| LYU | Accessory, Surgical Apparel | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Louis M. Gerson Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061375 | RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 | MSH | 2006-11-17 | 184 |
| K050193 | GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR | MSH | 2005-04-11 | 74 |
| K960778 | ISOLAIR APR TYPE N95 | MSH | 1996-05-09 | 73 |
| K925185 | ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS | FXX | 1994-02-03 | 477 |
| K931288 | ISOLAIR 2 FULL FACE SPLASH GUARD | LYU | 1994-01-21 | 315 |
| K922507 | GERSON ISOLAIR APR PARTICULATE SURGICAL MASK | FXX | 1992-11-16 | 173 |
| K881910 | LABELING CHANGE TO SURGICAL FACE MASK | FXX | 1988-05-18 | 19 |
| K802373 | SURGICAL FACE MASK | FXX | 1980-11-12 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Louis M. Gerson Co., 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Louis A. Serafin, Jr., M.D. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Louis M. Gerson Co., Inc.?
FDA lists 8 510(k) clearances under the applicant name “Louis M. Gerson Co., Inc.” (first 1980, latest 2006), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Louis M. Gerson Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Louis M. Gerson Co., Inc. is 124 days.
Which FDA product codes appear under Louis M. Gerson Co., Inc.?
The most frequent FDA product codes under this applicant name are FXX (Mask, Surgical, 4); MSH (Respirator, Surgical, 3); LYU (Accessory, Surgical Apparel, 1).
Next steps
- See all 8 Louis M. Gerson Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Louis M. Gerson Co., 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.