FDA product code PON: Catheter, Balloon, Dilation Of Cervical Canal
PON is the FDA product code for catheter, balloon, dilation of cervical canal. It is a Class II device, regulated under 21 CFR 884.4260 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under PON, from 2 different applicants. The average 510(k) review took 195 days (median 146).
Definition
Mechanical dilation and softening of the cervix.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Balloon, Dilation Of Cervical Canal |
| Device class | Class II |
| Regulation | 21 CFR 884.4260 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PON
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 147 |
| 2020 | 1 | 73 |
| 2021 | 1 | 416 |
Compare with all 510(k) review times · Search every PON clearance
Top PON applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gtimd, LLC | 3 | 2021-10-15 |
| Crossbay Medical | 1 | 2019-08-23 |
Most recent PON clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202433 | Gtimd, LLC | Aqueduct 200 Cervical Dilation Balloon Catheter | 2021-10-15 | 416 |
| K202427 | Gtimd, LLC | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | 2020-11-06 | 73 |
| K190813 | Crossbay Medical | CrossBay Cervical Dilator Catheter System | 2019-08-23 | 147 |
| K160664 | Gtimd, LLC | Aqueduct 100 Cervical Dilator | 2016-08-01 | 145 |
Recalls for PON devices
openFDA lists no recalls for product code PON.
Frequently asked questions
What is FDA product code PON?
PON is the FDA product code for catheter, balloon, dilation of cervical canal. It is a Class II device, regulated under 21 CFR 884.4260 and reviewed by the Obstetrics and Gynecology panel.
What device class is PON?
Class II, regulation 21 CFR 884.4260. Typical premarket route: 510(k).
How long does a 510(k) take for product code PON?
Across 4 cleared submissions the average was 195 days from receipt to decision (median 146).
Which companies have the most PON clearances?
Gtimd, LLC (3); Crossbay Medical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PON
- Run a recall and safety report across every PON manufacturer
- Watch product code PON 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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