FDA product code PUB: Accessory, Assisted Reproduction, Exempt
PUB is the FDA product code for accessory, assisted reproduction, exempt. It is a Class II device, regulated under 21 CFR 884.6120 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under PUB. The average 510(k) review took 272 days (median 272). FDA has posted 6 recalls for PUB devices, 6 initiated in the last five years.
Definition
This product code is the class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Classification
| Field | Value |
|---|---|
| Device name | Accessory, Assisted Reproduction, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 884.6120 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for PUB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 272 |
Compare with all 510(k) review times · Search every PUB clearance
Top PUB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| CooperSurgical, Inc. | 1 | 2020-01-14 |
Most recent PUB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191020 | CooperSurgical, Inc. | G210 InviCell Plus with SignipHy pH monitoring | 2020-01-14 | 272 |
Recalls for PUB devices
6 product recalls in 1 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2024-11-15.
| Year | Recalls |
|---|---|
| 2024 | 6 |
Frequently asked questions
What is FDA product code PUB?
PUB is the FDA product code for accessory, assisted reproduction, exempt. It is a Class II device, regulated under 21 CFR 884.6120 and reviewed by the Obstetrics and Gynecology panel.
What device class is PUB?
Class II, regulation 21 CFR 884.6120. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PUB?
Across 1 cleared submissions the average was 272 days from receipt to decision (median 272).
Which companies have the most PUB clearances?
CooperSurgical, Inc. (1).
Have PUB devices been recalled?
Yes: 6 product recalls across 1 recall events; the most recent began 2024-11-15.
Next steps
- Run an FDA pathway report with predicate devices for product code PUB
- Run a recall and safety report across every PUB manufacturer
- Watch product code PUB 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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