FDA product code IDL: Microtome, Accessories
IDL is the FDA product code for microtome, accessories. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. FDA has cleared 5 510(k) submissions under IDL, from 4 different applicants. The average 510(k) review took 28 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Microtome, Accessories |
| 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 IDL clearance
Top IDL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgipath Medical Industries, Inc. | 2 | 1986-09-25 |
| Polymer Technology Corp. | 1 | 1983-07-29 |
| American Optical Corp. | 1 | 1981-12-29 |
| Miles Laboratories, Inc. | 1 | 1980-07-28 |
Most recent IDL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863616 | Surgipath Medical Industries, Inc. | KNIFE MAKER | 1986-09-25 | 9 |
| K831921 | Polymer Technology Corp. | DISPOSABLE MICROTOME BLADES | 1983-07-29 | 45 |
| K831308 | Surgipath Medical Industries, Inc. | DISPOSABLE MICROTOME BLADE | 1983-05-16 | 24 |
| K813430 | American Optical Corp. | TISSUE PROCESSING CASSETTES & ACCESS | 1981-12-29 | 21 |
| K801426 | Miles Laboratories, Inc. | TISSUE-TEK III MICROJECT DISP. BLADE SYS | 1980-07-28 | 41 |
Recalls for IDL devices
openFDA lists no recalls for product code IDL.
Frequently asked questions
What is FDA product code IDL?
IDL is the FDA product code for microtome, accessories. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDL?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IDL?
Across 5 cleared submissions the average was 28 days from receipt to decision (median 24).
Which companies have the most IDL clearances?
Surgipath Medical Industries, Inc. (2); Polymer Technology Corp. (1); American Optical Corp. (1); Miles Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IDL
- Run a recall and safety report across every IDL manufacturer
- Watch product code IDL 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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