FDA product code IER: Polyethylene Glycol (Carbowax)

IER is the FDA product code for polyethylene glycol (carbowax). It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IER. The average 510(k) review took 32 days (median 32).

Classification

Compare with all 510(k) review times · Search every IER clearance

Top IER applicants

Most recent IER clearances

Recalls for IER devices

openFDA lists no recalls for product code IER.

Frequently asked questions

What is FDA product code IER?

IER is the FDA product code for polyethylene glycol (carbowax). It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.

What device class is IER?

Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code IER?

Across 1 cleared submissions the average was 32 days from receipt to decision (median 32).

Which companies have the most IER clearances?

Surgipath Medical Industries, Inc. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code IER
• Run a recall and safety report across every IER manufacturer
• Watch product code IER 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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