FDA product code FLF: Sterilizer, Ethylene-Oxide Gas
FLF is the FDA product code for sterilizer, ethylene-oxide gas. It is a Class II device, regulated under 21 CFR 880.6860 and reviewed by the General Hospital panel. FDA has cleared 26 510(k) submissions under FLF, from 20 different applicants. The average 510(k) review took 330 days (median 256). FDA has posted 8 recalls for FLF devices.
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer, Ethylene-Oxide Gas |
| Device class | Class II |
| Regulation | 21 CFR 880.6860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for FLF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 260 |
| 2020 | 1 | 385 |
Compare with all 510(k) review times · Search every FLF clearance
Top FLF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Andersen Sterilizers, Inc. | 3 | 2020-11-12 |
| 3M Company | 3 | 2015-01-08 |
| Tso3, Inc. | 2 | 2009-12-02 |
| Abtox, Inc. | 2 | 1994-12-22 |
| Technologies of Sterilization With Oxone, Tso3, Inc. | 1 | 2003-08-26 |
15 more applicants have FLF clearances. See the full list in Caduvo.
Most recent FLF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192978 | Andersen Sterilizers, Inc. | EOGas 4 Ethylene Oxide Gas Sterilizer | 2020-11-12 | 385 |
| K170432 | Andersen Sterilizers, Inc. | Anprolene AN75 Ethylene Oxide Gas Sterilizer | 2017-10-31 | 260 |
| K150646 | Andersen Sterilizers, Inc. | EOGas 4 Ethylene Oxide Gas Sterilizer | 2015-11-18 | 251 |
| K142034 | 3M Company | 3M STERI-VAC STERILIZER/AERATOR | 2015-01-08 | 164 |
| K090636 | Tso3, Inc. | TSO3 OZONE STERILIZER, MODEL 125L | 2009-12-02 | 267 |
Recalls for FLF devices
8 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-01-22.
Frequently asked questions
What is FDA product code FLF?
FLF is the FDA product code for sterilizer, ethylene-oxide gas. It is a Class II device, regulated under 21 CFR 880.6860 and reviewed by the General Hospital panel.
What device class is FLF?
Class II, regulation 21 CFR 880.6860. Typical premarket route: 510(k).
How long does a 510(k) take for product code FLF?
Across 26 cleared submissions the average was 330 days from receipt to decision (median 256).
Which companies have the most FLF clearances?
Andersen Sterilizers, Inc. (3); 3M Company (3); Tso3, Inc. (2); Abtox, Inc. (2); Technologies of Sterilization With Oxone, Tso3, Inc. (1).
Have FLF devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2016-01-22.
Next steps
- Run an FDA pathway report with predicate devices for product code FLF
- Run a recall and safety report across every FLF manufacturer
- Watch product code FLF 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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