FDA product code FMG: Stopcock, I.V. Set
FMG is the FDA product code for stopcock, i.v. set. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 89 510(k) submissions under FMG, 5 in the last five years, from 54 different applicants. The average 510(k) review took 94 days (median 68); 272 days on average over the last three years. FDA has posted 207 recalls for FMG devices, 49 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stopcock, I.V. Set |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| 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 FMG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 230 |
| 2019 | 2 | 143 |
| 2022 | 2 | 479 |
| 2023 | 2 | 196 |
| 2025 | 1 | 272 |
Compare with all 510(k) review times · Search every FMG clearance
Top FMG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Elcam Medical Acal | 8 | 2022-09-15 |
| Icu Medical, Inc. | 5 | 2009-02-25 |
| Tronomed, Inc. | 5 | 1980-01-16 |
| Ohmeda Medical | 4 | 1998-01-13 |
| Norton Performance Plastics Corp. | 4 | 1978-06-06 |
49 more applicants have FMG clearances. See the full list in Caduvo.
Most recent FMG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242255 | Medex | Qitexio® 4-Way Stopcock (QIT014) | 2025-04-29 | 272 |
| K223499 | M/S Romsons International | Three Way Stop Cock | 2023-07-21 | 242 |
| K223175 | Baxter Healthcare Corporation | lntravascular Administration Sets with Stopcock and Manifold | 2023-03-10 | 150 |
| K211204 | Elcam Medical Acal | SafePort(TM) Manifold (or Stopcock) | 2022-09-15 | 511 |
| K210516 | Yomura Technologies, Inc. | Clicky Cross | 2022-05-16 | 447 |
Recalls for FMG devices
207 product recalls in 34 recall events; 49 initiated in the last five years and 49 still open. Most recent: 2026-05-21.
| Year | Recalls |
|---|---|
| 2017 | 65 |
| 2018 | 29 |
| 2019 | 9 |
| 2020 | 5 |
| 2022 | 12 |
| 2025 | 34 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code FMG?
FMG is the FDA product code for stopcock, i.v. set. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is FMG?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code FMG?
Across 89 cleared submissions the average was 94 days from receipt to decision (median 68).
Which companies have the most FMG clearances?
Elcam Medical Acal (8); Icu Medical, Inc. (5); Tronomed, Inc. (5); Ohmeda Medical (4); Norton Performance Plastics Corp. (4).
Have FMG devices been recalled?
Yes: 207 product recalls across 34 recall events; the most recent began 2026-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code FMG
- Run a recall and safety report across every FMG manufacturer
- Watch product code FMG 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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