FDA product code MTW: System, Water, Reproduction, Assisted, And Purification
MTW is the FDA product code for system, water, reproduction, assisted, and purification. It is a Class II device, regulated under 21 CFR 884.6170 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under MTW, from 2 different applicants. The average 510(k) review took 168 days (median 168).
Classification
| Field | Value |
|---|---|
| Device name | System, Water, Reproduction, Assisted, And Purification |
| Device class | Class II |
| Regulation | 21 CFR 884.6170 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MTW clearance
Top MTW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Irvine Scientific Sales Co., Inc. | 1 | 2001-06-13 |
| Conception Technologies | 1 | 2000-08-02 |
Most recent MTW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011598 | Irvine Scientific Sales Co., Inc. | WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE | 2001-06-13 | 20 |
| K993140 | Conception Technologies | WATER FOR TISSUE CULTURE, MODELS 1500 | 2000-08-02 | 317 |
Recalls for MTW devices
openFDA lists no recalls for product code MTW.
Frequently asked questions
What is FDA product code MTW?
MTW is the FDA product code for system, water, reproduction, assisted, and purification. It is a Class II device, regulated under 21 CFR 884.6170 and reviewed by the Obstetrics and Gynecology panel.
What device class is MTW?
Class II, regulation 21 CFR 884.6170. Typical premarket route: 510(k).
How long does a 510(k) take for product code MTW?
Across 2 cleared submissions the average was 168 days from receipt to decision (median 168).
Which companies have the most MTW clearances?
Irvine Scientific Sales Co., Inc. (1); Conception Technologies (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MTW
- Run a recall and safety report across every MTW manufacturer
- Watch product code MTW 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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