Gam Industries, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Gam Industries, Inc.” (first 1992, latest 1994), across 9 product codes in 5 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 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | 1 | 1 |
| FPY | Sheet, Burn | 1 | 1 |
| HFW | Clamp, Umbilical | 1 | 1 |
| KBW | Screw, Oral | 1 | 1 |
| KGB | Mask, Oxygen, Non-Rebreathing | 1 | 1 |
| KME | Bedding, Disposable, Medical | 1 | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 | 1 |
Review panels
- General and Plastic Surgery (3)
- Anesthesiology (2)
- Obstetrics and Gynecology (2)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent Gam Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941641 | DISPOSABLE EMERGENCY OBSTETRICAL KIT | KNA | 1994-10-03 | 182 |
| K941336 | COMBO MASK | KGB | 1994-09-09 | 172 |
| K942021 | MOUTH TO MOUTH BREATHER | CBP | 1994-06-22 | 57 |
| K936050 | JAW SPREADER | KBW | 1994-03-24 | 94 |
| K930401 | ALUMINUM FOIL | MGP | 1993-05-12 | 106 |
| K926290 | BURN SHEET | FPY | 1993-04-20 | 127 |
| K925590 | MULTI-TRAUMA DRESSING | NAB | 1993-04-08 | 154 |
| K915569 | UMBILICAL CLAMP | HFW | 1992-09-23 | 286 |
| K915303 | FOIL BABY BUNTING | KME | 1992-02-20 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Gam Industries, 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 Gam Industries, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Gam Industries, Inc.” (first 1992, latest 1994), across 9 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 Gam Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gam Industries, Inc. is 127 days.
Which FDA product codes appear under Gam Industries, Inc.?
The most frequent FDA product codes under this applicant name are CBP (Valve, Non-Rebreathing, 1); FPY (Sheet, Burn, 1); HFW (Clamp, Umbilical, 1).
Next steps
- See all 9 Gam Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBP, Gam Industries, 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.