FDA product code IDS: Melting Pot, Paraffin
IDS is the FDA product code for melting pot, paraffin. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IDS. The average 510(k) review took 21 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Melting Pot, Paraffin |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top IDS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warner-Lambert Co. | 1 | 1982-07-13 |
Most recent IDS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821831 | Warner-Lambert Co. | A O HISTOSTAT EMBEDDING CTR #8030,32,34 | 1982-07-13 | 21 |
Recalls for IDS devices
openFDA lists no recalls for product code IDS.
Frequently asked questions
What is FDA product code IDS?
IDS is the FDA product code for melting pot, paraffin. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDS?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IDS?
Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most IDS clearances?
Warner-Lambert Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IDS
- Run a recall and safety report across every IDS manufacturer
- Watch product code IDS 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.