FDA product code IDO: Microtome, Rotary
IDO is the FDA product code for microtome, rotary. 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 IDO, from 3 different applicants. The average 510(k) review took 33 days (median 21). FDA has posted 1 recall for IDO devices.
Classification
| Field | Value |
|---|---|
| Device name | Microtome, Rotary |
| 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 IDO clearance
Top IDO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lkb Instruments, Inc. | 3 | 1987-01-05 |
| Surgipath Medical Industries, Inc. | 1 | 1986-09-19 |
| Miles Laboratories, Inc. | 1 | 1981-09-29 |
Most recent IDO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K864733 | Lkb Instruments, Inc. | LKB 2260 MACROTOME | 1987-01-05 | 32 |
| K863548 | Surgipath Medical Industries, Inc. | ROTARY MICROTOME | 1986-09-19 | 7 |
| K843505 | Lkb Instruments, Inc. | LKB 2230 ROTARY ONE | 1984-11-30 | 85 |
| K812558 | Miles Laboratories, Inc. | TISSUE-TEK III ACCU-CUT ROTARY MICROTOME | 1981-09-29 | 21 |
| K812157 | Lkb Instruments, Inc. | LKB-BROMMA 2218 HISTORANGE MICROTOME | 1981-08-18 | 20 |
Recalls for IDO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-08-12.
Frequently asked questions
What is FDA product code IDO?
IDO is the FDA product code for microtome, rotary. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDO?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IDO?
Across 5 cleared submissions the average was 33 days from receipt to decision (median 21).
Which companies have the most IDO clearances?
Lkb Instruments, Inc. (3); Surgipath Medical Industries, Inc. (1); Miles Laboratories, Inc. (1).
Have IDO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-08-12.
Next steps
- Run an FDA pathway report with predicate devices for product code IDO
- Run a recall and safety report across every IDO manufacturer
- Watch product code IDO 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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