FDA product code IEO: Processor, Tissue, Automated
IEO is the FDA product code for processor, tissue, automated. It is a Class I device, regulated under 21 CFR 864.3875 and reviewed by the Pathology panel. FDA has cleared 12 510(k) submissions under IEO, from 5 different applicants. The average 510(k) review took 61 days (median 52). FDA has posted 11 recalls for IEO devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Processor, Tissue, Automated |
| Device class | Class I |
| Regulation | 21 CFR 864.3875 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IEO clearance
Top IEO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovative Medical Systems, Inc. | 5 | 1992-12-29 |
| Miles Laboratories, Inc. | 4 | 1983-07-28 |
| Sakura Finetek U.S.A., Inc. | 1 | 1988-07-01 |
| Lkb Instruments, Inc. | 1 | 1984-11-30 |
| Technicon Instruments Corp. | 1 | 1984-02-04 |
Most recent IEO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924590 | Innovative Medical Systems, Inc. | MICROWAVE AUTOMATED TISSUE PROCESSOR | 1992-12-29 | 110 |
| K883599 | Innovative Medical Systems, Inc. | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | 1988-09-02 | 10 |
| K881165 | Sakura Finetek U.S.A., Inc. | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR | 1988-07-01 | 103 |
| K853938 | Innovative Medical Systems, Inc. | LX 300 TISSUE PROCESSOR | 1985-10-10 | 16 |
| K851054 | Innovative Medical Systems, Inc. | LX120 TISSUE PROCESSOR | 1985-05-15 | 62 |
Recalls for IEO devices
11 product recalls in 11 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2025-04-02.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code IEO?
IEO is the FDA product code for processor, tissue, automated. It is a Class I device, regulated under 21 CFR 864.3875 and reviewed by the Pathology panel.
What device class is IEO?
Class I, regulation 21 CFR 864.3875. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IEO?
Across 12 cleared submissions the average was 61 days from receipt to decision (median 52).
Which companies have the most IEO clearances?
Innovative Medical Systems, Inc. (5); Miles Laboratories, Inc. (4); Sakura Finetek U.S.A., Inc. (1); Lkb Instruments, Inc. (1); Technicon Instruments Corp. (1).
Have IEO devices been recalled?
Yes: 11 product recalls across 11 recall events; the most recent began 2025-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code IEO
- Run a recall and safety report across every IEO manufacturer
- Watch product code IEO 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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