FDA product code FLN: Monitor, Electric For Gravity Flow Infusion Systems
FLN is the FDA product code for monitor, electric for gravity flow infusion systems. It is a Class II device, regulated under 21 CFR 880.2420 and reviewed by the General Hospital panel. FDA has cleared 39 510(k) submissions under FLN, from 35 different applicants. The average 510(k) review took 93 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Electric For Gravity Flow Infusion Systems |
| Device class | Class II |
| Regulation | 21 CFR 880.2420 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FLN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 303 |
Compare with all 510(k) review times · Search every FLN clearance
Top FLN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Imed Corp. | 4 | 1983-07-12 |
| Travenol Laboratories, S.A. | 2 | 1985-04-04 |
| Shift Labs, Inc. | 1 | 2018-05-25 |
| Shift Labs | 1 | 2015-10-13 |
| Coleman Laboratories | 1 | 2014-04-24 |
30 more applicants have FLN clearances. See the full list in Caduvo.
Most recent FLN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172242 | Shift Labs, Inc. | DripAssist Plus | 2018-05-25 | 303 |
| K150687 | Shift Labs | DripAssist | 2015-10-13 | 210 |
| K133870 | Coleman Laboratories | FLUID LEVEL MONITOR | 2014-04-24 | 125 |
| K080704 | Em-Tec GmbH | LOW FLUID ALARM | 2008-04-17 | 36 |
| K050783 | Integrated Sensing Systems, Inc. | ISSYS DRUG FLOW MONITOR | 2006-02-22 | 331 |
Recalls for FLN devices
openFDA lists no recalls for product code FLN.
Frequently asked questions
What is FDA product code FLN?
FLN is the FDA product code for monitor, electric for gravity flow infusion systems. It is a Class II device, regulated under 21 CFR 880.2420 and reviewed by the General Hospital panel.
What device class is FLN?
Class II, regulation 21 CFR 880.2420. Typical premarket route: 510(k).
How long does a 510(k) take for product code FLN?
Across 39 cleared submissions the average was 93 days from receipt to decision (median 72).
Which companies have the most FLN clearances?
Imed Corp. (4); Travenol Laboratories, S.A. (2); Shift Labs, Inc. (1); Shift Labs (1); Coleman Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FLN
- Run a recall and safety report across every FLN manufacturer
- Watch product code FLN 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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