FDA product code FLS: Monitor, Apnea, Facility Use
FLS is the FDA product code for monitor, apnea, facility use. It is a Class II device, regulated under 21 CFR 868.2377 and reviewed by the Anesthesiology panel. FDA has cleared 16 510(k) submissions under FLS, from 16 different applicants. The average 510(k) review took 112 days (median 84). FDA has posted 2 recalls for FLS devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Apnea, Facility Use |
| Device class | Class II |
| Regulation | 21 CFR 868.2377 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FLS clearance
Top FLS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Respironics Georgia, Inc. | 1 | 2002-01-11 |
| Ilife Systems, Inc. | 1 | 2000-01-12 |
| Airsep Corp. | 1 | 1996-10-25 |
| Protocol Systems, Inc. | 1 | 1996-02-02 |
| Hogan & Hartson | 1 | 1989-10-30 |
11 more applicants have FLS clearances. See the full list in Caduvo.
Most recent FLS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011597 | Respironics Georgia, Inc. | SMARTMONITOR 2, MODEL 4000 | 2002-01-11 | 232 |
| K991087 | Ilife Systems, Inc. | HANNAH WIRELESS VITAL SIGNS MONITOR | 2000-01-12 | 287 |
| K962865 | Airsep Corp. | REMBRANDT SYSTEM | 1996-10-25 | 94 |
| K951246 | Protocol Systems, Inc. | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS | 1996-02-02 | 319 |
| K894973 | Hogan & Hartson | RESPITRACE PLUS | 1989-10-30 | 84 |
Recalls for FLS devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-04-23.
Frequently asked questions
What is FDA product code FLS?
FLS is the FDA product code for monitor, apnea, facility use. It is a Class II device, regulated under 21 CFR 868.2377 and reviewed by the Anesthesiology panel.
What device class is FLS?
Class II, regulation 21 CFR 868.2377. Typical premarket route: 510(k).
How long does a 510(k) take for product code FLS?
Across 16 cleared submissions the average was 112 days from receipt to decision (median 84).
Which companies have the most FLS clearances?
Respironics Georgia, Inc. (1); Ilife Systems, Inc. (1); Airsep Corp. (1); Protocol Systems, Inc. (1); Hogan & Hartson (1).
Have FLS devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2009-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code FLS
- Run a recall and safety report across every FLS manufacturer
- Watch product code FLS 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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