FDA product code FLI: Cabinet, Ethylene-Oxide Gas Aerator
FLI is the FDA product code for cabinet, ethylene-oxide gas aerator. It is a Class II device, regulated under 21 CFR 880.6100 and reviewed by the General Hospital panel. FDA has cleared 8 510(k) submissions under FLI, from 6 different applicants. The average 510(k) review took 56 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Cabinet, Ethylene-Oxide Gas Aerator |
| Device class | Class II |
| Regulation | 21 CFR 880.6100 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FLI clearance
Top FLI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Castle Co. | 3 | 1983-06-15 |
| 3M Health Care, Ltd. | 1 | 1990-12-05 |
| Gas-Vak | 1 | 1990-10-15 |
| Bear Medical Systems, Inc. | 1 | 1983-04-12 |
| Sybron Corp. | 1 | 1981-12-31 |
1 more applicants have FLI clearances. See the full list in Caduvo.
Most recent FLI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904921 | 3M Health Care, Ltd. | STERI-VAC(TM) AERATOR MODEL XL | 1990-12-05 | 35 |
| K902906 | Gas-Vak | GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR | 1990-10-15 | 104 |
| K831595 | Castle Co. | CASTLE MODEL 3341 & 3441 & 4141 GAS AER | 1983-06-15 | 29 |
| K830165 | Bear Medical Systems, Inc. | BEAR JET 150 VENTILATOR | 1983-04-12 | 84 |
| K813201 | Sybron Corp. | CASTLE #3241 GAS AERATOR | 1981-12-31 | 48 |
Recalls for FLI devices
openFDA lists no recalls for product code FLI.
Frequently asked questions
What is FDA product code FLI?
FLI is the FDA product code for cabinet, ethylene-oxide gas aerator. It is a Class II device, regulated under 21 CFR 880.6100 and reviewed by the General Hospital panel.
What device class is FLI?
Class II, regulation 21 CFR 880.6100. Typical premarket route: 510(k).
How long does a 510(k) take for product code FLI?
Across 8 cleared submissions the average was 56 days from receipt to decision (median 54).
Which companies have the most FLI clearances?
Castle Co. (3); 3M Health Care, Ltd. (1); Gas-Vak (1); Bear Medical Systems, Inc. (1); Sybron Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FLI
- Run a recall and safety report across every FLI manufacturer
- Watch product code FLI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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