FDA product code IDP: Microtome, Cryostat
IDP is the FDA product code for microtome, cryostat. 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 IDP. The average 510(k) review took 12 days (median 12). FDA has posted 10 recalls for IDP devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Microtome, Cryostat |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IDP clearance
Top IDP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Exakt Medical Instruments, Inc. | 1 | 1988-08-29 |
Most recent IDP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883514 | Exakt Medical Instruments, Inc. | EXAKT CUTTING & GRINDING SYSTEM | 1988-08-29 | 12 |
Recalls for IDP devices
10 product recalls in 4 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2025-01-30.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2024 | 6 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code IDP?
IDP is the FDA product code for microtome, cryostat. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDP?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IDP?
Across 1 cleared submissions the average was 12 days from receipt to decision (median 12).
Which companies have the most IDP clearances?
Exakt Medical Instruments, Inc. (1).
Have IDP devices been recalled?
Yes: 10 product recalls across 4 recall events; the most recent began 2025-01-30.
Next steps
- Run an FDA pathway report with predicate devices for product code IDP
- Run a recall and safety report across every IDP manufacturer
- Watch product code IDP 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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